Senior Product Development Engineer - Medical Devices

Sirtex Medical; Woburn (MA); Hybrid; USD 151,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision and life ins.

401(k) with matching

Paid sick and vacation time

Flexible work arrangements

Job summary

Sirtex Medical in the Boston area is hiring a Principal Product Development Engineer to serve as the senior technical authority for complex medical device programs. You will lead design controls, verification, validation, and regulatory submissions from concept through commercialization, while mentoring engineers and guiding cross-functional teams.

This hands-on leadership role requires deep product development experience, strong communication, and a collaborative approach to drive innovation in

Qualifications

• BS/MS in Biomedical, Mechanical or related engineering with 12+ years (BS) or 10+ years (MS) of medical device product development.
• Hands-on authorship of Design Verification, IV, IQ/OQ/PQ protocols and reports.
• Experience with 21 CFR 820 / QMSR, ISO 13485, ISO 14971, ISO 10993.

Responsibilities

• Serve as project lead on multiple development programs from user needs to launch.
• Collaborate with Quality, Manufacturing, Regulatory and Marketing.
• Own Design History File content and lead design reviews for traceability.
• Drive concept generation and protect innovations via disclosures and patents.
• Lead R&D modules of FDA submissions (PMA/IDE/510(k)) and EU MDR documentation.

Skills

Technical leadership

Regulatory submission

Design controls

Verification & Validation

Written communication

3D CAD (SolidWorks)

Statistics (Minitab/JMP)

Risk management (ISO 14971)

Project leadership

Education

BS in Biomedical/Mechanical or related

MS in Biomedical/Mechanical or related

Tools

SolidWorks

Minitab

JMP

Job description

Sirtex Medical in the Boston area is hiring a Principal Product Development Engineer to serve as the senior technical authority for complex medical device programs. You will lead design controls, verification, validation, and regulatory submissions from concept through commercialization, while mentoring engineers and guiding cross-functional teams.

This hands-on leadership role requires deep product development experience, strong communication, and a collaborative approach to drive innovation in