Job#: 3054806 Job Description: R&D Engineer (Design Controls / DHF Remediation)
Location: Mansfield, Massachusetts (Onsite)
Type: Contract
Compensation: $30-34/hr.
Role Overview We are seeking an R&D Engineer to support Design History File (DHF) remediation activities for regulated healthcare products. This role will focus on assessing existing design documentation, identifying gaps against industry standards and internal procedures, developing technical rationales, and supporting design control activities to ensure regulatory compliance.
Key Responsibilities- Review and remediate Design History Files (DHFs) for compliance with applicable regulations and quality standards.
- Conduct gap assessments against internal procedures and industry requirements.
- Develop technical justifications and engineering rationales for design decisions.
- Support design control activities throughout the product lifecycle.
- Collaborate with Quality, Regulatory, and Product Development teams.
- Update and maintain engineering documentation, traceability, and design records.
- Participate in design verification, validation, and risk-management activities as needed.
Preferred Qualifications- BS in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related discipline.
- Experience within medical device, healthcare, or other regulated industries.
- Knowledge of Design Controls, DHFs, FDA regulations, and ISO 13485.
- Experience with product development, design assurance, or remediation projects.
- Strong technical writing and documentation skills.
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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