Principal Product Development Engineer — Hybrid Leader

Sirtex; Woburn (MA); Hybride; USD 151 000 - 175 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision

401(k) matching

Paid time off

Résumé du poste

Sirtex Medical is hiring a Principal Product Development Engineer to serve as the senior technical authority for device programs from concept through commercialization. You will lead cross-functional teams, define design controls, and own verification, validation, and regulatory submissions.

This hands-on leadership role requires mentoring engineers, defending evidence for PMA/IDE/510(k) submissions, and driving design transfers with manufacturing partners in a hybrid Boston, MA environment.

Qualifications

• BS in Biomedical or Mechanical engineering with 12+ years of device development experience, or MS with 10+ years.
• Experience leading Class II/III PMA devices through design controls and product launches.
• Experience in FDA PMA, IDE or 510(k) submissions.
• Working knowledge of 21 CFR 820 / ISO 13485 / ISO 14971 / ISO 10993.
• Clear, concise technical writing and the ability to explain risk to leadership.
• Experience with IEC 62366-1 and FDA HF guidance is a plus.
• Track record in mentoring engineers.
• Experience in growth-stage or startup environments.

Responsabilités

• Lead development programs from user needs through design transfer and launch.
• Collaborate with Quality, Manufacturing, Regulatory and Marketing.
• Own DHF content and lead design reviews with traceability from needs to evidence.
• Drive concept generation and feasibility work; file invention disclosures and patents.
• Define user needs with clinicians and translate into testable requirements.
• Lead Design Verification and support transfer to manufacturing (IQ/OQ/PQ).
• Manage external labs for testing and assess impact of changes.
• Mentor engineers and review protocols, reports and design decisions.

Connaissances

Technical leadership

Design reviews

Regulatory submissions

Mentor engineers

Cross-functional collaboration

FDA PMA submissions

Statistical analysis

Formation

BS/MS in Biomedical/Mechanical engineering

Outils

SolidWorks

Minitab

JMP

Description du poste

Sirtex Medical is hiring a Principal Product Development Engineer to serve as the senior technical authority for device programs from concept through commercialization. You will lead cross-functional teams, define design controls, and own verification, validation, and regulatory submissions.

This hands-on leadership role requires mentoring engineers, defending evidence for PMA/IDE/510(k) submissions, and driving design transfers with manufacturing partners in a hybrid Boston, MA environment.