Sr. Development Engineer

Key Responsibilities

• Support DHF/RMF remediation and close documentation gaps.
• Review design controls, design inputs/outputs, and traceability.
• Support design verification, validation, and risk management documentation.
• Coordinate with Quality, Regulatory, Manufacturing, and Engineering teams.
• Maintain remediation plans, timelines, and project status.

Required Skills

• 3–5 years of engineering experience.
• Bachelor's degree in a relevant engineering discipline.
• Medical Device Design Controls and DHF/RMF experience preferred.
• Working knowledge of ASME GD&T.
• Knowledge of medical-device quality and regulatory standards.
• Microsoft Office proficiency.
• Cognition Cockpit and Minitab experience preferred.