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PURPOSE AND SCOPE: The Sr. Engineer possesses specific product lines knowledge to be a resource and key technical expert to support related projects. The Sr. Engineer is largely unsupervised and self-motivated to lead projects. Shall be capable of being given high level tasks and working independently to organize work, from required Cross Functional Teams (CFT) and to produce the final product or outcome assigned. The Sr. Engineer is expected to be trusted to provide production support to ensure product reliability, dependability and efficient manufacturability. The Sr. Engineer is also capable of formulating new research projects - from starting with a concept, formulating a pre-development plan and completing a feasibility study. The Sr. Engineer can act as the expert in a cross technical team (CTT) to execute a project and/or solve hard to diagnose problems. The Sr. Engineer, as a technical expert, may be called upon to provide system related technical seminars across the company.
PRINCIPAL DUTIES AND RESPONSIBILITIES: • Applies the education and experience to develop, maintain and resolve any issues with assigned systems of responsibility. • Subject matter expert role at all stages from converting lab scale technology into a commercial medical product to supporting the released product. • Is familiar with and follows FDA/ISO Design Control principles and regulations in product development. • Designs and develops products that meet User inputs and supports business and marketing strategies to further generate revenue growth. • Applies Risk based procedures throughout the product development process and the product life cycle. • Authors testing plans, engineering test reports, and position and/or white papers using good documentation practices • Encouraged to generate of idea for potential inventions. • Act as a Project Leader for major projects assigned (concept through release). • Participate as a CFT or CTT member as assigned. • Develops and establishes detailed Design (engineering) input specifications to ensure product function, minimized patient risk and cost effective manufacturing. • Develops and gives presentations dealing with projects, proposals, designs and project status updates. • Assist in development of custom equipment to support small-scale product assembly and testing. • Assist in producing manufacturing procedures. • Prepare and deliver assigned presentations. • Executes projects with clear objectives and timely deliverables. Understand the goals and contents of development and research projects. • Foster culture of collaboration with CFT members, CTT members and inner/inter departmental personnel. • Interfaces regularly with vendors/consultants based on responsibilities and assignments. • Provide assistance to manufacturing in establishing product fabrication facilities and procedures as part of Design Transfer. Maintain observation of production statistics to ensure production equipment and processes are effective. Provides technical support to other departments as assigned. • Maintain clean workspaces. • Provide mentoring and assistance to Engineer II and I level staff. • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. • Works under Minimal supervision and may be asked to contribute to performance evaluations of other employees. • Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS: • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISION: • None
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EDUCATION: • Bachelor’s Degree in related engineering or scientific discipline required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS: • 5 – 8 years’ related experience; • Master’s degree with >3 years’ related experience; • PhD without experience; or equivalent directly related work experience.
ACKNOWLEDGEMENT: I acknowledge that I have read and accepted this job description. I understand what is expected of me in this position, and I am able to perform the essential functions as outlined with or without reasonable accommodation. Furthermore, I understand that the duties and responsibilities listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. If I have any questions about duties and responsibilities not specified in this job description that I am asked to perform, I should discuss them with my immediate supervisor or my Human Resources representative. Employee Name (Please Print) Employee Signature Date
ADDENDUM:
Chemical Systems • Design, develop, and test adsorptive and ion exchange materials for a chemical based medical device. • Design studies to assess chemical technologies and materials for use in unconventional home hemodialysis products. • Design, conduct, and champion innovative experimental solutions to enhance product/process performance, safety, and reliability • Perform scientific/engineering experimentation and research on materials, products, and processes. • Evaluate systems/components and make recommendations for improvements and solutions. • Participate in development and optimization of algorithms for product design that may include schematic design, electromechanical components and prototype testing for use with a chemical based medical device. • Work with other senior personnel to drive fast-paced learning and implementation of new learning. • Regularly evaluate the performance of each member of the team and provide candid and constructive feedback. • Actively seek and coordinate professional development and improvement opportunities for the members of the team. • Contribute at a high level on cross-functional teams within the organization. • Propagate culture of rigorous mathematics, fundamental science, and sound engineering in all work. • Foster culture of collaboration, knowledge transfer, and continuous learning at all times.
Education • Bachelor’s Degree in Chemical Engineering, Materials Engineering, Mechanical Engineering, or other related engineering discipline required. • Advanced Degree (MS, PhD) preferred.
Employee Name (Please Print) Employee Signature Date
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Process Development • Explore, innovate, and develop chemical processes for a chemical based medical device. • Devise, conduct, and champion innovative experimental solutions to enhance product/process performance, safety, and reliability. • Evaluate processes, instrumentation, and equipment and make recommendations for improvements/solutions. • Develop and recommend new process formulas and technologies to achieve cost effectiveness and improved product quality. • Perform scientific/engineering experimentation and research on materials, products, and processes. • Identify and implement equipment and processes from prototype to pilot scale manufacturing and establish tracking metrics to ensure ongoing quality. • Work with other senior personnel to drive fast-paced learning and implementation of new learning. • Contribute at a high level on cross-functional teams within the organization. • Actively seek and coordinate professional development and improvement opportunities for self and other members of the team. • Propagate culture of rigorous mathematics, fundamental science, and sound engineering in all work. • Foster culture of collaboration, knowledge transfer, and continuous learning at all times.
Education • Bachelor’s Degree in Chemical Engineering or other related engineering discipline required. • Advanced Degree (MS, PhD) preferred.
Working Conditions While performing the duties of the Engineer, the employee is required to work in an office and laboratory environment. Capable of lifting 35 lb with assistance, as required. Extended periods of standing and sitting may be required. Capable of working in moderate to excessive noise levels. Exposed to corrosive, caustic, and/or reactive chemicals, compressed gases, dust, and flammable solvents.
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Systems Verification • Works as a team member to develop & execute system verification plans, protocols and reports for multiple projects by analyzing system requirements. • Acts as technical contact in the company to provide decisions and recommendations for system verification aspects of projects. • Participates in system verification plans and protocol reviews and other related design reviews. • Works with product development teams to evaluate system interfaces, operational requirements, and performance requirements. • Creates, identifies, validates, and uses test tools that facilitate data gathering and test method execution. • Participates in the design, build, validation and deployment of effective test automation solutions. • Understands defect management and works closely with System Engineers on defect resolution. • Maintains effective communication with the project manager, and team members on project scope, timelines, and design changes. • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. • Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead). Networks with key contacts outside of area of expertise. • Develops technical solutions for complex problems that require the regular use of ingenuity and creativity. • Provides assistance to other staff with complex tasks that require considerable judgment and initiative. • Reports work progress, issues and risks to project managers and supervisors. • Assists with various projects as assigned by direct supervisor. • Other duties as assigned. EDUCATION:
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• Bachelor’s Degree in Electrical Engineering, Computer Engineering, or equivalent technical degree required; Advanced Degree desirable. Qualifications and Skills: • BS in engineering discipline or a related field. • 7+ years of experience performing system verification in Class II (or above) medical devices. • 5+ years developing scripts for automated system verification testing. • 2+ years leading system verification activities in Class II (or above) medical devices. • Strong understanding of product development process related to medical devices. • Knowledge of regulatory (FDA) and applicable standards ISO 13485, ISO 14971 is desirable. • Strong interpersonal skills with a team focus. • Proactive and self-directed. • Ability to be productive and stay focused on deliverables in a fast-paced working environment.
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Software Engineering • Experience in the full software development life cycle using IEC 62304. • Provide technical solutions of wide range of difficult software engineering problems. • Evaluate systems/components and make recommendations for improvements and solutions. • Leads in debug and test of integrated software using software and hardware tools as needed. • Leads in code reviews and other related design reviews. • Work with other senior personnel to drive fast-paced learning and implementation of new learning. • Regularly evaluate the performance of each member of the team and provide candid and constructive feedback. • Actively seek and coordinate professional development and improvement opportunities for the members of the team. • Contribute at a high level on cross-functional teams within the organization. • Foster culture of collaboration, knowledge transfer, and continuous learning at all times. • Proficiency in C/C++, Java and/or Assembly/other programming languages and complete understanding of technical principals, theories and concepts in the software engineering field, preferable in the medical device area. • Full understanding of real time embedded operating systems as well as inter-processor communications and control. • Experience to bring up a new hardware board or system with initial board support package. • Proficient in GUI and device driver development in different operating system environment and/or real time embedded microprocessor programming. • Proficient with integrated development environments, software source control and general software practices. • Experience in TCP/IP and other method of communications. • Requires excellent problem solving skills.
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Software Verification • Works as a team member to design, develop and modify Software verification plans, protocols and reports for multiple projects by analyzing software requirements and following the appropriate software development process. • Executes test protocols, and writes reports to describe program evaluation, testing, and correction. • Acts as technical contact in the company to provide decisions and recommendations for software verification aspects of projects. • Participates in software verification plans and protocol reviews and other related design reviews. • Works with product development teams to evaluate system interfaces, operational requirements, and performance requirements, and testability software. • Creates, identifies, validates, and uses test tools that facilitate data gathering and test method execution. • Participates in the design, build, validation and deployment of effective test automation solutions. • Understands defect management and works closely with Software Engineers on defect resolution. • Maintains effective communication with the project manager, and team members on project scope, timelines, and design changes. • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. • Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
Experience and Required Skills • Demonstrated understanding of principles, theories and concepts in the software engineering field, preferably in the medical device area. • Software quality assurance experience in a product development environment • Experience with C, or assembly-level code development, embedded processing and I/O control. • Experience using tools to test and troubleshoot software applications. • Excellent organizational and verbal/written communication skills. • Strong interpersonal skills with ability to work effectively in a team or individually with supervision. • Highly motivated and energetic. Passion for creating high quality medical device software and systems. • Experience in development of automated test scripts is preferred. • Experience and familiarity with ISO 13485 and IEC 62304, and with FDA GMP is preferred. • Experience with sensors, microprocessor/microcontroller and/or FPGA based digital design is preferred.
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Packaging Engineering • Acts as a subject matter expert regarding the research and development of innovative disposable product packaging. • Supports project activities that require focus on packaging and transportation of disposables products. • Supports new product design transfer into manufacturing, especially activities related to product packaging, including specification development, test method validation and automation for packaging. • Participates and leads risk management activities related to product packaging. • Develops and executes product shipping study protocols and final reports, e.g. ASTM D4169, with coordination of internal and external transit test equipment/laboratory. • Engages GRD, Strategic Procurement, manufacturing and packaging material suppliers to develop new packaging for existing or new products, including detailed engineering specifications and drawings. • Hands-on involvement with fabrication of packaging prototypes for bag, pouch, foil, corrugated box, pallet, corner board, stretch wrap, slip sheet, buckle and other material or medium used for product packaging and transportation. • Develops and validates new techniques and test methods related to product integrity testing when neither ISO or ASTM standards are commonly available to the specific needs of Fresenius disposable products. • Uses computerized tools to aid in product packaging integrity analysis, load strength maximization and compression ratio studies, e.g. CAPES, TOPPS and other common industry software for packaging and transportation design/analysis. • Uses hand tools, small power tools and test equipment.
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Dialyzer Development • Design, develop and test materials/prototypes for medical devices • Design studies to assess technologies and materials for use in unconventional hemodialysis products • Design, conduct and champion innovative experimental solutions to enhance product. process performance, safety and reliability • Perform scientific/engineering experimentation and research on materials, products, and processes • Evaluate Systems/components and make recommendations for improvements and solutions • Work with other senior personnel to drive fast-paced learning and implementation from new learning • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results • Assist in evaluating the performance of members of the team and provide candid and constructive feedback • Actively seek and coordinate professional development and improvement opportunities for the members of the team • Contribute at a high level on cross-functional teams within the organization • Propagate culture of rigorous mathematics, fundamental science, and sound engineering in all work • Foster culture of collaboration, knowledge transfer, and continuous learning at all times • Maintains effective communication with project manager, and team members on project scope, timelines and design changes
Working Conditions While performing duties, the employee is required to work in an office and laboratory environment. Capable of lifting 35 lb with assistance, as required. Extended periods of standing and sitting may be required. Capable of working in moderate to excessive noise levels. Exposed to corrosive, caustic, and/or reactive chemicals, compressed gases, dust, and flammable solvents.
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Electrical Development Engineering • Excellent problem solver skill demonstrated over a wide range of difficult electrical engineering problems. • Evaluate components and make recommendations for improvements and solutions. • Demonstrates good judgment in selecting methods and techniques for obtaining solutions. • Leads in debug and test of hardware using software and hardware tools as needed. • Leads in peer reviews and other related design reviews. • Works with other senior personnel to drive fast-paced learning and implementation of new learning. • Keeps abreast of state-of-the-art of electronics and related technologies to ensure safety and quality of Fresenius products.
These Duties and Responsibilities do not apply: • Assist in producing manufacturing procedures. • Assist in development of custom equipment to support small-scale product assembly and testing. • Provide assistance to manufacturing in establishing product fabrication facilities and procedures as part of Design Transfer. Maintain observation of production statistics to ensure production equipment and processes are effective. Provides technical support to other departments as assigned.
Education: • Bachelor’s Degree with emphasis in Electrical Engineering required; Advanced Degree desirable.
Experience and required skills: • Experience in medium-to- complex electronics board design including concept, requirements, schematic design entry, circuit simulation, PCB layout, board bring-up, troubleshooting and release to manufacturing. • Experience with digital and/or analog (sensors, data acquisition, power systems) design. • Experience and mastery of schematic and PCB design tools. • Experience with microprocessor/microcontroller and/or FPGA based digital design • Experience in high speed digital design/ impedance control applied to printed circuit board and cabling technology. • Experience with printed circuit board manufacturing process in effectively applying DFM and DFT. • Experience in use of tools to test and troubleshoot electrical circuit boards such as oscilloscope, logic analyzer, etc. • Excellent organizational and verbal/written communication skills. • Applies statistical methods in evaluating and determining design parameters/limits. • Highly motivated and energetic. Passion for creating high quality medical device hardware. • FPGA design using Verilog or VHDL development languages and associated design software /simulation tools a plus • Experience with SPICE analog simulation a plus. • Experience in investigational analysis methods such as DFMEA, Design of Experiments a plus. • Familiarity with IPC standards and the IEC 60601 family of safety standards a plus.
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Requirement Engineering • Evaluate GRD supported tool systems/configurations and make recommendations for improvements and solutions • Leads in debug and test of tool configurations or coding solutions as needed • Provide technical solutions of wide range of difficult configuration management problems • Understand and implement concepts relating to Applications Lifecycle Management and relate them to the Applications Engineering environment • Technically proficient in the specific department and knowledge of industry practice and business principles • Train users and work with cross-functional teams on functionality and use of GRD supported tools • Apply concepts of FDA design controls, risk management, and process validation (IQ/OQ/PQ) • Knowledge of regulatory FDA and applicable standards • Contribute at a high level on cross-functional teams within the organization • Requires excellent problem solving skills
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Biocompatibility • Define biocompatibility requirements for medical device and pharmaceutical products • Determine testing and evaluation strategies to assess potential biological safety risks for materials contact with the human body • Design chemistry studies to characterize extractable/leachable chemicals from Fresenius’ products. • Support toxicological risk assessments of extractable/leachable chemicals, and derivation of allowable limits • Interface with cross-functional teams for product development, and support project execution and prioritization • Partner with internal and external laboratories for new test method development • Manage contract laboratory relationships, including cost and quality improvements • Participate in development of international standards for biological safety evaluation of medical devices • Propagate culture of rigorous science and drive process improvement for biocompatibility group • Provide technical leadership and support for issue resolution within biocompatibility group and cross-functional teams • Provide assistance to other staff with complex evaluations that require considerable judgment and initiative Employee Name (Please Print) Employee Signature Date
Systems Engineering
PRINCIPAL DUTIES AND RESPONSIBILTIES: • Establishes product requirements and interface design definition by collaborating with cross-functional disciplines within the product development environment. • Conducts product safety analysis and develop design solutions to mitigate risks. Utilizes risk analysis to enhance safety and design robustness. • Provides technical guidance and support external and internal customers throughout the product life cycle. Conduct feasibility of potential technical solutions and allocation of derived requirements onto affected subsystem. • Specifies and develops improvements or enhancements to existing products and champion implementation if necessary. • Develops the planning, organization, implementation, and monitoring of requirement management processes, tools, risk, and issue tracking. • Contributes to development of design verification and design validation protocols. • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. • Demonstrates good judgment in selecting methods and techniques for obtaining solutions. • Networks with senior internal and external personnel in own area of expertise. • Normally receives little instruction on day-to-day work, general instructions on new assignments.
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EXPERIENCE AND REQUIRED SKILLS: • Experience in developing customer and product requirements, translating requirements into systems level architecture designs and interface design definitions, and requirement allocation. • Strong hands-on skills in complex system design, integration, testing, and troubleshooting. Familiar with quality management system, product safety analysis, risk assessment and mitigation, and dFMEA/ pFMEA/Use-MisUse FMEA/FTA. • Experience in medical device development. • Strong preference for experience with requirements management, modeling and issue/defect tracking tools e.g. DOORS, Cognition Cockpit, Jira, TFS, SysML, MagicDraw etc. • Excellent oral and written communication skills with ability to interact directly with cross-functional team members, and external partners. • Excellent analytical and problem solving skills in mechanical and electrical systems. Hydraulics experience preferred. • Strong preference for experience with FDA design controls and ISO 14971 risk management. • Experience with modeling and simulation tools such as MATLAB, Labview, or Simulink preferred. • Dialysis products experience preferred.
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Instrumentation Electronic • Demonstrate design experience in analog circuits • Demonstrate design experience in digital circuits • Demonstrate experience in software structure and coding • Proficient solder skill: Build circuits (including surface mount) and troubleshoot from a schematic diagram • Design circuits, review circuits, create schematics and related documentation • Oversee creation of circuit boards, loading them and troubleshooting them • Expert knowledge in use of test equipment (e.g. Oscilloscope, Spectrum Analyzer, etc.) • Understanding of materials the selection of components • Understanding of solid state device theory and applications of components • Expert in different grounding schemes and rationale • Expert in combining mixed signal environments • Designation of light emission and detection devices • Knowledge of RF shielding and grounding techniques – a plus • Proficiency in working with medical blood lab equipment • Knowledge of blood lab techniques, performing blood runs and maintaining a blood lab • Understanding of blood borne pathogens and proficiency in use of Personal Protective Equipment • Works independently with minimal supervision • Leads projects and participates on cross-functional teams and is proficient in Design and Change Control processes • Supervises/mentors subordinate engineers as assigned/required Employee Name (Please Print) Employee Signature Date
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Instrumentation Mechanical • Demonstrate proficiency in at least the Solidworks program and how to operate it. • Proficiency in the Fresenius drafting and drawing protocols • Demonstrated ability to write and perform technical test protocols and write technical reports • Functional experience in the design of plastic and Metal parts • Experience in packaging electronics into enclosures (minimal vibration, required heat transfer, etc.) • Demonstrate proficiency in the use of mechanical equipment (e.g. Mill, lathe, drill press etc.) • Knowledge of electrical circuits, Volt / Ohm meters usage and Oscilloscope usage. • Experience in control of light emission, detection and various optical devices – a plus • An understanding of medical blood lab equipment and its operation – • Ability to execute blood lab techniques, handle blood runs in a blood lab • Awareness of blood borne pathogens and use of Personal Protective Equipment • Works independently with little supervision • Leads projects and participates on cross-functional teams and is proficient in Design and Change Control processes • Supervises/mentors subordinates software engineers as assigned/required Employee Name (Please Print) Employee Signature Date
Instrumentation Software • Demonstrate direct experience of interfacing digital and analog circuits • Show experience with software structure and coding • Advanced ability to program at the machine/processor level (Languages of interest: C, Assembly, C+, C++) • Capable user of test equipment (e.g. Oscilloscope, Network Analyzer, etc.) • Designer of real time code structures, interrupt servicing modules and operating kernels • Able to comfortably combine mixed signal environments • Experience in control of light emission, detection and various optical devices – a plus • An understanding of medical blood lab equipment and its operation – able to interface with these devices to write database and analysis software for Windows. • Ability to execute blood lab techniques, handle blood runs in a blood lab to verify and validate code functions • Awareness of blood borne pathogens and use of Personal Protective Equipment • Works independently with little supervision • Leads projects and participates on cross-functional teams and is proficient in Design and Change Control processes • Supervises/mentors subordinates software engineers as assigned/required Employee Name (Please Print) Employee Signature Date
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Mechanical • Excellent problem solver skill demonstrated over a wide range of difficult Mechanical engineering problems. • Evaluate components and make recommendations for improvements and solutions. • Demonstrates good judgment in selecting methods and techniques for obtaining solutions. • Leads in peer reviews and other related design reviews. • Contributes to the design, development or modification of mechanical hardware for a limited scope of a project by analyzing the hardware requirements and specifications documents. • Authors and implements engineering test reports and change notices. • Lead design reviews and other related technical reviews. • Review Engineering Inputs and write verification plan and verification protocols and execute. • Write Engineering Inputs. • Write DFMEA’s. • Experience and understanding in engineering materials in plastics and metals • Experience and understanding in rapid prototyping process; SLA, SLS and CNC. • Experience and understanding in finite element analysis • Experience in solid modeling (Solid Works and/or Creo) • Experience and understanding with tolerance analysis. • Review Engineering Inputs and write verification plan and verification protocols and execute. • Write Engineering Inputs • Experience and understanding of developing drawings and ability to understand and apply ANSI standards to drawings. • General understanding of material science, thermodynamics and fluid dynamics. • Ability to interface cross functionally. • Experience developing test and troubleshoot mechanical subsystems. • Works effectively within organization to evaluate project results. • Performs unstructured testing. • Must comply with FDA Design Control. • Ability to develop and adhere to project time lines • Communicate project progress frequently and effectively to managers and team members
Education: • Bachelor’s Degree in Mechanical Engineering required; Advanced Degree desirable Employee Name (Please Print) Employee Signature Date
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Mechatronics Engineer • Experience and understanding in engineering materials in plastics and metals • Experience and understanding in plastic manufacturing processes; high pressure injection molding, low • pressure injection molding • Experience and understanding in plastic bonding methods and bonding materials and adhesives • Experience and understanding in metal manufacturing processes; sheet metal, die cast, investment, extrusion process and machining. • Experience and understanding in rapid prototyping process; SLA, SLS and CNC. • Experience and understanding in finite element analysis • Experience and understanding in computational fluid dynamics • Experience in solid modeling (Solid Works and/or Creo) • Experience and understanding in developing drawings and ability to understand and apply ANSI standards to drawings. • Experience in development and verification of electro-mechanical subsystems. • General understanding of material science, thermodynamics and fluid dynamics. • Develop, test and troubleshoot electro-mechanical subsystems. • Experience writing engineering test reports. • Experience in writing reliability plans, protocols and reports. • Experience in writing design verification plans, protocols and reports. • Performs unstructured testing of electro-mechanical systems • Work with outside vendors to acquire new component for use in electro-mechanical system • Must comply with FDA Design Control • Experience and understanding in analog circuits • Experience and understanding in digital circuits • Ability to troubleshoot analog and digital circuits • Experience and understanding in the use of test equipment (oscilloscopes, spectrum analyzers) • Ability to work in a mixed signal environment • Experience and understanding in light emission and detection devices • Experience and understanding of RF shield and grounding techniques
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Supervision • May be responsible for direct supervision of up to three employees.
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Systems Analyst • Must have experience with business systems analysis • Authors/translates functional specifications from marketing requirements, creates data flow diagrams and system context diagrams. • Analyzes and understands the data structure and their relationships. • Work with Software System Designers and has strong System Design skills. Data Modelling experience is preferred. • Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. • May provide assistance to lower level staff with more complex tasks that require a higher level of understanding of functions. Mentors other staff as applicable. • Regulated industry experience is preferred. • Previous experience in a large healthcare or other business conglomerate supporting cross functional business system data flow analysis across a multi-application and partner landscape. • Assists with various projects • Bachelor’s Degree required; Software Development or IT/MIS background is preferred. • Minimum of 5 years of related experience with at least 1 year in a large-scale project. • Excellent presentation and communication skills required. • Strong organizational, project management, and process analysis skills are essential. • Must be able to lead virtual project teams across broad-based projects. Employee Name (Please Print) Employee Signature Date
Biomedical Engineer – System Validation/Verification
Design, develop and implement functional verification and validation plans and systems for dialysis machines. These electromechanical, FDA-regulated devices operate on embedded and systems-level software which require verification and validation during the Research & Development process and into production and manufacturing of the devices.
Specific duties will include:
• Provide leadership to team members on best practices for Verification and Validation execution as it applies to key medical device methodologies, FDA design controls and quality system requirements • Lead verification plans and protocol reviews and help the broader Team migrate to more agile development methodologies. Ensure that verification documents follow internal Fresenius guidelines and processes for embedded software functionality per the Quality Systems Regulations (21 CFR part 820) and ISO 13485 standards. • Design and develop verification tools and systems required to ensure the proper and regulatory compliant operation of hemodialysis and peritoneal dialysis medical devices. Select and configure tools for exercising and collecting data from completed and implemented test cases in compliance with ISO 62304, ISO 13485 QMS and ISO 14971 Risk Management. • Design and conduct tests and write test protocols for evaluating and analyzing all aspects of medical software safety. Generating comprehensive test reports from executed test protocols that ensure output content complies with dialysis treatment safety levels and expected outcomes. • Design and develop tools and systems that can diagnose performance issues with embedded systems and can track medical data generated by our devices. • Design and develop medical diagnostic and clinical instrumentation, equipment, and procedures, using the principles of engineering and biobehavioral sciences/Human Factors Engineering. • Provide technical support for biomedical devices. • Design and develop verification tools and process to address new or enhanced functionality of medical devices. • Define, approve and execute test protocols and write reports to describe program evaluation, testing, and correction. Performing both positive and negative dialysis treatment tests on equipment for thorough coverage and creating regression tests to verify defects found during execution of test protocols and ensuring end-to-end clinical use cases are represented. • Serve as a primary embedded and systems-level software verification liaison and provide recommendations and guidance on testing and assessing the functionality of medical devices in development.
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• Work with the Product Development team to evaluate system interfaces, identify driving clinical and operational use cases/gaps, and assess operational requirements, performance requirements and testability. • Create, identify, validate and use embedded software and system test tools that facilitate data gathering and test method execution • Lead the design, build, validation, and deployment of effective test automation solutions.
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