Job#: 3058805 Job Description: US Development Sr Engineer I
Location: Warsaw, Indiana (Remote)
Role Overview
The Design Quality and Design Assurance Engineer supports the remediation of existing product Design History Files (DHF) and Risk Management Files (RMF). This position focuses on closing documentation gaps, strengthening traceability, and providing engineering support for product changes, design controls, and quality activities. The selected candidate will collaborate with cross-functional teams to resolve documentation discrepancies and ensure compliance with medical device standards.
Key Responsibilities
- Applies product, clinical, regulatory, and standards knowledge to legacy DHF and RMF remediation.
- Reviews available user needs and intended-use documentation for completeness and consistency.
- Checks traceability among user needs, design inputs, outputs, and supporting verification or validation evidence.
- Reviews design rationale and supporting records, updating documentation to address identified gaps.
- Identifies and coordinates the retrieval of objective evidence needed to complete DHF and RMF records.
- Coordinates with cross-functional teams to locate and assess design verification, validation, and process-validation evidence.
- Reviews production specifications and inspection records for consistency with design documentation.
- Links critical-to-quality features and inspection evidence to applicable design requirements and risks.
- Partners with Quality, Regulatory, Manufacturing, and Sourcing to resolve documentation gaps and obtain approvals.
- Authors, reviews, and routes DHF and RMF remediation updates for cross-functional approval under applicable procedures.
Required Qualifications
Education: Minimum of a Bachelor of Science degree from an ABET accredited school, or global equivalent, in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering, or Aeronautical Engineering.
Experience: Three to five years of full-time professional engineering experience within a regulated industry.
Technical Skills: Proficiency with Microsoft Office Suite software and working knowledge of ASME GD&T applied to product design are required. Experience with medical device design controls and DHF/RMF remediation is required, alongside knowledge of manufacturing processes and materials used in medical device design.
Preferred Qualifications
- Experience with the Cognition Cockpit Platform or electronic DHF systems.
- Demonstrated working knowledge of statistics with application to sample size determination, design of experiments, and null hypothesis testing, with Minitab experience.
- Design for Six Sigma experience or certification.
- Experience with biologics products.
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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