Job Title: US Development Sr Engineer IJob DescriptionThis role is focused on supporting the remediation of existing product Design History Files (DHF) and Risk Management Files (RMF), aiming to close documentation gaps and enhance traceability. The position also involves providing engineering support for product changes, design controls, and quality activities.
Responsibilities
- Apply product, clinical, regulatory, and standards knowledge to legacy DHF/RMF remediation.
- Review user needs and intended-use documentation for completeness and consistency.
- Check traceability among user needs, design inputs, outputs, and supporting verification/validation evidence; document gaps for remediation.
- Review design rationale and supporting records; update documentation to address identified gaps.
- Identify and coordinate retrieval of objective evidence needed to complete DHF/RMF records.
- Coordinate with cross-functional teams to locate and assess design verification, validation, and process-validation evidence.
- Review production specifications and inspection records for completeness and consistency with design documentation.
- Link critical-to-quality features and inspection evidence to applicable design requirements and risks.
- Review design verification, validation, and risk-control evidence against requirements and applicable procedures.
- Partner with Quality, Regulatory, Manufacturing, and Sourcing to resolve documentation gaps and obtain approvals.
- Assess test-method documentation and supporting evidence; identify gaps requiring follow-up.
- Author, review, and route DHF/RMF remediation updates for cross-functional approval under applicable procedures.
- Provide DHF/RMF evidence to support regulatory submissions and inquiries, as assigned.
- Coordinate review of relevant clinical evidence for completeness and alignment with design and risk records.
- Support Quality and Post-Market Surveillance investigations by reviewing related design and risk records.
- Maintain remediation plans, timelines, and status; communicate progress to stakeholders.
- Escalate resource needs, blockers, and overdue remediation actions.
- Coordinate cross-functional remediation reviews as needed.
- Track action owners, deliverables, and due dates through closure.
- Report remediation status and unresolved issues to leadership.
- Identify remediation risks, agree mitigations with stakeholders, and escalate issues requiring direction.
Essential Skills
- Mechanical engineering and biomedical engineering expertise.
- Proficiency in GD&T applied to product design.
- Experience with medical-device design controls and DHF/RMF remediation preferred.
- Knowledge of manufacturing processes and materials used in medical-device design and production.
- Understanding of applicable medical-device quality and regulatory requirements and standards.
- Proficiency in Microsoft Office Suite.
- Ability to communicate clearly in written and verbal forms across functions and regions.
- Minimum degree from an ABET accredited school or equivalent in relevant engineering disciplines.
- 3 to 5 years of full-time engineering experience.
Additional Skills & Qualifications
- Design for Six Sigma experience.
- Experience with biologics products is desirable.
- Working knowledge of statistics with application to sample size determination, design of experiments, and null hypothesis testing preferred.
- Minitab experience desired.
- Proficiency in Cognition Cockpit Platform (Electronic DHF System) is beneficial.
Work EnvironmentThis is a remote position, with a preference for candidates within driving distance from Grand Rapids or Austin, TX. Preferred time zones are Eastern or Central. Job Type & LocationThis is a Contract position based out of Warsaw, IN. Pay and BenefitsThe pay range for this position is $38.00 - $46.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & LocationThis is a Contract position based out of Warsaw, IN. Application DeadlineThis position is anticipated to close on Nov 21, 2026. Workplace TypeThis is a fully remote position.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI):
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