Function: Design Quality / R&D Engineering 

Reports To: Manager, Design Assurance / Director, Design Quality 

Level: Senior Engineer (Individual Contributor) 

Location: Hybrid / On-Site (varies by site) 

Position Summary 

The DHF Remediation Engineer is responsible for leading the systematic gap assessment, reconstruction, and remediation of Design History Files (DHFs) for legacy and on-market medical devices, including Class II and Class III products and combination products. Working within the Design Assurance function and partnering with R&D, Regulatory Affairs, Risk Management, and Manufacturing, the incumbent ensures that design control records meet current expectations under 21 CFR 820.30, ISO 13485:2016, ISO 14971:2019, and EU MDR 2017/745. This role is highly hands-on: the Engineer authors, reviews, and approves design control deliverables and serves as a technical lead for cross-functional remediation programs driven by internal audits, FDA inspectional observations, Notified Body findings, MDR transitions, or CAPA commitments. 

Key Responsibilities 

• Lead end-to-end DHF gap analyses across Design Inputs, Design Outputs, Design Verification, Design Validation, Design Reviews, Design Transfer, and Design Changes, including traceability matrices linking user needs through verification evidence. 

• Author, revise, and approve design control deliverables, including Design Input Requirements (DIRs), Design Output specifications, V&V protocols and reports, traceability matrices, and Design Review records. 

• Drive Design Risk Management remediation in accordance with ISO 14971:2019, including hazard analyses, dFMEA / uFMEA / pFMEA, harm tables, risk/benefit assessments, and post-market risk file maintenance. 

• Develop and execute remediation plans with defined scope, severity tiering, timelines, and acceptance criteria; coordinate workstreams across multiple product families and disconnected legacy systems. 

• Reconstruct missing or incomplete design history records using engineering rationale, equivalence justifications, leveraged testing, and statistical bridging arguments where direct evidence is not available. 

• Lead cross-functional Design Reviews and ensure each remediation deliverable is independently reviewed and signed off in accordance with the QMS. 

• Serve as design control subject matter expert during internal audits, FDA inspections, Notified Body audits, and customer/partner audits; author audit responses and remediation commitments. 

• Coordinate Design Transfer and Design Change activities for remediated products and ensure that manufacturing and supplier documentation align with the remediated DHF. 

• Mentor junior engineers and contractors on design controls methodology, risk management, and technical writing standards. 

• Identify systemic gaps in the QMS or in design control SOPs, and partner with Quality Systems to drive procedural improvements that feed into CAPA. 

Required Qualifications 

• Bachelor's degree in Biomedical, Mechanical, Electrical, Chemical, or related Engineering discipline. 

• Minimum 6–8 years of medical device industry experience, with at least 4 years directly executing design controls and/or DHF remediation activities. 

• Demonstrated experience leading or executing at least one full DHF remediation program for a Class II or Class III device, combination product, or SaMD. 

• Deep working knowledge of 21 CFR 820.30, ISO 13485:2016, ISO 14971:2019, IEC 62366-1 (usability), and EU MDR 2017/745 Annex II Technical Documentation requirements. 

• Hands-on authoring experience with design input requirements, V&V protocols/reports, traceability matrices, and risk management files. 

• Proven ability to write technical rationale and justification arguments that withstand regulator and Notified Body scrutiny. 

• Strong cross-functional collaboration skills with R&D, RA, Clinical, Manufacturing, and Supplier Quality. 

Preferred Qualifications 

• Master's degree in Engineering, Regulatory Affairs, or related discipline. 

• Experience with Class III, implantable, or combination products (drug-device, biologic-device). 

• Experience with electro-mechanical devices, energy-based devices, or endoscopic/imaging platforms (e.g., scope-based capital equipment). 

• Prior experience supporting an FDA 483, Warning Letter, Consent Decree, or Notified Body NCR response. 

• Working knowledge of IEC 60601, IEC 62304, ISO 10993, and applicable particular standards. 

• Familiarity with PLM/QMS platforms such as Windchill, Agile, Veeva Vault QMS, MasterControl, or ETQ Reliance. 

• ASQ CQE, CSQE, or RAC certification.