Development Sr Engineer I

Our client, a Medical Devices/Healthcare company, is looking for a Development Sr Engineer I for their Remote location.

Responsibilities:

• 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.
• 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.

Requirements:

• 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.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities