Staff Medical Device Engineer - Hybrid Lead, Design Controls

Sirtex; Woburn (MA); Hybrid; USD 124,000 - 155,000; Full time

Benefits offered by this job

401(k) matching

Medical, dental, vision

Paid time off

Job summary

Sirtex Medical is hiring a Staff Product Development Engineer to serve as the senior technical authority on development programs—from concept through commercialization and sustaining. This hands‑on leadership role sets technical direction for cross‑functional teams and mentors engineers, while owning design controls, verification, validation and regulatory submissions to support PMA, IDE or 510(k).

Candidates must be local to the Boston, MA area with a hybrid work arrangement (3 days in office,

Qualifications

• BS/MS in Biomedical or Mechanical engineering with medical device experience.
• Demonstrated technical leadership on PMA devices and design controls.
• Experience with Design Verification, Validation and Process Validation protocols.

Responsibilities

• Lead development programs from user needs through commercial launch.
• Own Design History File content and design reviews with traceability.
• Drive risk management and regulatory submissions (PMA/IDE/510(k)).

Job description

Sirtex Medical is hiring a Staff Product Development Engineer to serve as the senior technical authority on development programs—from concept through commercialization and sustaining. This hands‑on leadership role sets technical direction for cross‑functional teams and mentors engineers, while owning design controls, verification, validation and regulatory submissions to support PMA, IDE or 510(k).

Candidates must be local to the Boston, MA area with a hybrid work arrangement (3 days in office,