Development Sr Engineer II

Provides technical leadership for Design History File remediation initiatives, including gap assessments, design control reconstruction, traceability establishment, objective evidence identification, and preparation of DHF documentation supporting regulatory inspections, technical documentation submissions, and product lifecycle compliance activities. Partners with cross-functional stakeholders to resolve historical documentation gaps, establish design traceability, and support internal audits, regulatory inspections, submissions, and product lifecycle activities.

Conducts comprehensive assessments of Design History Files to identify documentation gaps, missing objective evidence, and design control deficiencies.

Develops and executes remediation plans to correct, reconstruct, and close design documentation gaps.

Establishes and user needs, design inputs, design outputs, verification, validation, risk management, and design changes.

Performs technical reviews of historical engineering documentation to determine compliance with design control requirements.

Coordinates cross-functional remediation activities involving Engineering, Quality, Regulatory Affairs, Clinical, Operations, and Manufacturing teams.

Authors and reviews remediation reports, gap assessments, engineering rationales, traceability matrices, and design control deliverables.

Supports remediation of legacy product documentation to ensure completeness, consistency, and regulatory compliance.

Ensures design changes, risk evaluations, verification, and validation activities are appropriately documented and linked within the DHF.

Prepares and executes responses to design control nonconformances, audit observations, and regulatory findings.

Provides technical leadership for remediation activities associated with CAPAs impacting design documentation or design controls.maintains traceability between

Leadership of complex DHF remediation and design control compliance programs.

Advanced knowledge of design controls and lifecycle documentation.

Development and remediation of Design History Files and supporting technical documentation.

Creation and maintenance of requirements, traceability matrices, and design documentation structures.

Review and assessment of design inputs, design outputs, verification, validation, and design change records.

Risk management integration within the design control process.

Technical writing and documentation reconstruction for legacy products.

Regulatory inspection readiness and audit support.

Cross-functional leadership and influence across Quality, Regulatory, Clinical, and Engineering disciplines.

Experience with design controls under FDA Design Control requirements, ISO 13485, and EU MDR.

Experience developing traceability matrices linking user needs, requirements, risks, verification, validation, and design changes.

Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience required.

B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering,

Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering highly preferred.

Demonstrated experience authoring, reviewing, maintaining, or remediating Design History Files (DHFs) and technical documentation.

5 to 7 years of engineering work experience highly preferred.

Up to 5% travel might be required.

Expected compensation for the role is $119,000 - 149,000 base per year plus performance bonuses.

EOE