Senior Medical Device Engineer - Lead PMA & Design Controls

Sirtex; Woburn (MA); Hybrid; USD 95,000 - 119,000; Full time

Job summary

Sirtex Medical in the Boston area is seeking a Sr. Product Development Engineer to serve as the senior technical authority. You will lead multiple development programs, own design controls, and drive regulatory submissions from concept through commercialization.

This hands-on leadership role includes mentoring engineers and setting direction for cross-functional teams. The position is hybrid (3 days in office, 2 remote) in Woburn, MA, with a base salary range and a 5% target bonus.

Qualifications

• BS degree in one of the above disciplines and 7+ years of medical device product development experience.
• Demonstrated technical leadership of Class II and/or Class III PMA devices through design controls, design transfer and commercial launch.
• Hands-on authorship of Design Verification, Test Method Validation and Process Validation (IQ/OQ/PQ) protocols and reports.
• Working command of 21 CFR 820 / QMSR, ISO 13485, ISO 14971 and ISO 10993.
• Clear, concise technical writing and the ability to explain risk to leadership.

Responsibilities

• Serve as project lead on concurrent development programs from user needs to commercial launch.
• Collaborate with Quality, Manufacturing, Regulatory and Marketing.
• Own Design History File content and lead design reviews with traceability.
• Drive concept generation and protect innovations via disclosures and patents.
• Lead Design Verification and support transfer to manufacturing (IQ/OQ/PQ).
• Mentor engineers and review protocols, reports and design decisions.

Skills

Project leadership

Technical leadership

Regulatory submissions

Cross-functional collaboration

Design verification/validation

Statistical analysis

Technical writing

Mentoring engineers

Startup/fast-paced environment

Education

BS/MS in engineering

Tools

SolidWorks

Minitab

JMP

Job description

Sirtex Medical in the Boston area is seeking a Sr. Product Development Engineer to serve as the senior technical authority. You will lead multiple development programs, own design controls, and drive regulatory submissions from concept through commercialization.

This hands-on leadership role includes mentoring engineers and setting direction for cross-functional teams. The position is hybrid (3 days in office, 2 remote) in Woburn, MA, with a base salary range and a 5% target bonus.