Principal Product Development Engineer

• Compensation: USD 150,553 - USD 175,000 - yearly

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer.

To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

About the role

Sirtex Medical is hiring a Principal Product Development Engineer to serve as the senior individual-contributor technical authority. You will provide project leadership, own the technical integrity of design controls, verification, validation and regulatory submissions from concept through commercialization and sustaining.

This is a hands-on leadership role. You will set technical direction for cross-functional teams, write and defend the evidence that gets products approved and keeps them on the market, and mentor engineers who will grow into the next generation of technical leads.

Candidates must be local to the Boston, MA area and be willing to adhere to our hybrid work arrangements, currently 3 days/week in office and 2 days/week remote.

Location:

Woburn, MA — hybrid/on-site

Key responsibilities

• Serve as project lead on one or more concurrent development programs, from user needs and design inputs through design transfer and commercial launch
• Collaborate closely with Quality, Manufacturing, Regulatory and Marketing
• Own Design History File content and lead formal design reviews, ensuring traceability from user needs to verification and validation evidence
• Drive concept generation and feasibility work and protect resulting innovations through invention disclosures and patent filings
• Engage marketing team and clinicians to define user needs and translate them into testable requirements
• Lead and own Design Verification
• Work in partnership with manufacturing and design quality to support transfer to manufacturing / Process Validation (IQ/OQ/PQ)
• Manage external labs for testing including testing plan development, reports and assess the impact of design, material and supplier changes
• Act as a subject matter expert for biological safety and provide strategy
• Lead R&D modules of FDA submissions (PMA, PMA supplements, IDE, 510(k)) and EU MDR Technical Documentation, and respond to Regulatory and Notified Body questions
• Partner with Quality on design risk management per ISO 14971, owning the engineering inputs to DFMEA/PFMEA and benefit-risk analysis
• Participate in complaint investigations, root cause analysis and CAPA, and support FDA inspections and audits when needed
• Partner with Quality and Manufacturing on product and process improvements
• Mentor and develop…