Position Title: US Development Sr Engineer I
Work Location: Remote
Assignment Duration: 12 months
Position Summary:
This role primarily supports remediation of existing product Design History Files (DHF) and Risk Management Files (RMF), closing documentation gaps and strengthening traceability.
It also provides engineering support for product changes, design controls and quality activities.
Key Responsibilities:
Applies product, clinical, regulatory and standards knowledge to legacy DHF/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/validation evidence; documents gaps for remediation.
Reviews design rationale and supporting records; updates documentation to address identified gaps.
Identifies and coordinates retrieval of objective evidence needed to complete DHF/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 completeness and consistency with design documentation.
Links critical-to-quality features and inspection evidence to applicable design requirements and risks.
Reviews design verification, validation and risk-control evidence against requirements and applicable procedures.
Partners with Quality, Regulatory, Manufacturing and Sourcing to resolve documentation gaps and obtain approvals.
Assesses test-method documentation and supporting evidence; identifies gaps requiring follow-up.
Authors, reviews and routes DHF/RMF remediation updates for cross-functional approval under applicable procedures.
Provides DHF/RMF evidence to support regulatory submissions and inquiries, as assigned.
Coordinates review of relevant clinical evidence for completeness and alignment with design and risk records.
Supports Quality and Post-Market Surveillance investigations by reviewing related design and risk records.
Maintains remediation plans, timelines and status; communicates progress to stakeholders.
Escalates resource needs, blockers and overdue remediation actions.
Coordinates cross-functional remediation reviews as needed.
Tracks action owners, deliverables and due dates through closure.
Reports remediation status and unresolved issues to leadership.
Identifies remediation risks, agrees mitigations with stakeholders and escalates issues requiring direction.
Qualification & Experience:
Clear written and verbal communication; able to work across functions and regions.
Design for Six Sigma experience desired.
Microsoft Office Suite software proficiency required.
Experience with medical-device design controls and DHF/RMF remediation preferred; biologics products desirable.
Working knowledge of ASME GD&T applied to product design required.
Knowledge of manufacturing processes and materials used in medical-device design and production.
Knowledge of applicable medical-device quality and regulatory requirements and standards required; global requirements preferred.
Demonstrated 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).
Minimum 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.
3 to 5 years of full-time engineering experience.