Sr. Development Engineer

The Development Engineer will focus on post-market activities for existing medical device Design History Files, ensuring documentation is complete, accurate, and compliant. Working under the guidance of a project leader, this role manages design documentation, supports risk analysis, and drives verification and validation activities while collaborating closely with cross-functional teams. The engineer contributes directly to maintaining product quality and regulatory readiness through meticulous technical documentation and review.

• Author and review existing Design History Files (DHF) for medical devices, identifying scope and documenting gaps where necessary records are missing.
• Utilize Vault systems to manage document workflows, ensuring that all design and risk documentation is properly controlled and updated.
• Generate, analyze, and update risk documentation, including Design Failure Mode and Effects Analysis (DFMEA) and risk tables, to support ongoing product safety and compliance.
• Coordinate, prepare, and conduct design reviews with cross-functional teams, including Regulatory and Quality, to drive alignment and expedite critical project tasks.
• Perform functional relationship analyses (FRA) and tolerance stack-ups to validate design robustness and manufacturability.
• Develop comprehensive protocols to test and analyze products for design verification and design validation (V&V), ensuring that performance and quality requirements are met.
• Update engineering prints and other design and manufacturing elements to reflect current product configurations and standards.
• Establish and refine process methods that meet defined performance and quality requirements for post-market design activities.
• Prepare clear, concise technical reports and documentation to support regulatory submissions, quality audits, and internal design reviews.
• Deliver effective oral presentations to communicate technical findings, project status, and recommendations to stakeholders.

• Strong background in authoring and executing Design History File (DHF) documentation for medical devices.
• Familiarity with Vault systems and experience managing document workflows in a controlled environment.
• Proficiency with drafting standards and geometric dimensioning and tolerancing (GD&T).
• Ability to perform functional relationship analyses (FRA) and tolerance stack-ups for mechanical and related components.
• Experience generating and updating risk documentation such as DFMEA and risk tables.
• Ability to work effectively within cross-functional teams, including Regulatory and Quality, to expedite completion of critical project tasks.
• Strong technical writing skills for creating protocols, reports, and design documentation.
• Ability to give clear and concise oral presentations to technical and non-technical audiences.
• Proficiency with the Microsoft Office Suite for documentation, data analysis, and presentations.
• Self-starter and self-motivated work style, with strong organizational skills and attention to detail.
• Excellent communication and teamwork skills to support collaborative post-market engineering activities.

• B.S. degree from an ABET-accredited school (or global equivalent) in Biomedical, Mechanical, or Materials Engineering, or an equivalent engineering discipline.
• Experience with medical device design verification and validation (V&V) protocol development and execution.
• Experience updating prints and other design and manufacturing elements in support of post-market changes.
• Ability to establish and refine process methods that consistently meet performance and quality requirements.
• Comfort working under the…