Development Engineer

Title: Development Sr Engineer I

Pay: $36-$38 per hour

Type: Remote Warsaw Indiana

Duration: 1 year

Position Overview:

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:

DHF/RMF Remediation and Traceability

• Apply product, clinical, regulatory, and standards knowledge to legacy DHF/RMF remediation.
• Review available 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.
• Author, review, and route DHF/RMF remediation updates for cross-functional approval under applicable procedures.

Verification, Validation, and Manufacturing Evidence

• 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.
• Assess test-method documentation and supporting evidence; identify gaps requiring follow-up.

Cross-Functional, Regulatory, and Quality Support

• Partner with Quality, Regulatory, Manufacturing, and Sourcing to resolve documentation gaps and obtain approvals.
• 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.

Remediation Planning and Tracking

• 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 on mitigations with stakeholders, and escalate issues requiring direction.

Qualifications:

• 3–5 years of full-time engineering experience.
• Minimum B.S. degree from an ABET-accredited school, or global equivalent, in one of the following disciplines:
• Mechanical Engineering or Mechanical Engineering Technology
• Biomedical Engineering or Biomedical Engineering Technology
• Bioengineering or Bioengineering Technology
• Aerospace Engineering
• Aeronautical Engineering
• Clear written and verbal communication; ability to work across functions and regions.
• Microsoft Office Suite proficiency.
• Working knowledge of ASME GD&T applied to product design.
• Knowledge of manufacturing processes and materials used in medical-device design and production.
• Knowledge of applicable medical-device quality and regulatory requirements and standards.
• Proficiency in Cognition Cockpit Platform, an electronic DHF system.

Preferred Qualifications:

• Experience with medical-device design controls and DHF/RMF remediation.
• Biologics product experience.
• Knowledge of global medical-device requirements.
• Design for Six Sigma experience.
• Working knowledge of statistics applied to sample size determination, design of experiments, and null hypothesis testing.
• Minitab experience.