Principal Product Development Engineer

Sirtex•Woburn, MA

1h•$150,553 - $175,000•Hybrid

About The Position

Sirtex Medical is hiring a Principal Product Development Engineer to serve as its senior individual-contributor technical authority. This hands-on leadership role provides project leadership and owns the technical integrity of design controls, verification, validation, and regulatory submissions from concept through commercialization and sustaining. The engineer sets technical direction for cross-functional teams, develops and defends evidence supporting product approvals and continued market access, and mentors engineers. The role is based in Woburn, Massachusetts, and requires candidates to be local to the Boston area and follow a hybrid schedule of three days per week in the office and two days per week remotely.

Requirements

Bachelor's degree in Biomedical, Mechanical, or a related engineering discipline with 12 or more years of medical device product development experience, or a master's degree with 10 or more years of 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 ability to explain risk and trade-offs to executive leadership and non-engineering audiences.
Experience leading the R&D module in FDA PMA, IDE, or 510(k) submissions.
Experience leading root cause investigations, complaint handling, and CAPA.
Basic proficiency with 3D CAD tools such as SolidWorks and statistical analysis tools such as Minitab or JMP.
Track record managing or mentoring engineers, co-ops, or interns.
Candidates must be local to the Boston, Massachusetts area and willing to follow the hybrid work arrangement.

Nice To Haves

Hands-on experience with IEC 62366-1 and FDA HFE guidance, including use-related risk analysis, formative studies, critical task identification, and summative (HF validation) testing and reporting.
Formal training in statistical problem-solving, such as Six Sigma.
Experience in a growth-stage or startup environment where wearing multiple hats was the norm.

Responsibilities

Lead one or more concurrent development programs from user needs and design inputs through design transfer and commercial launch.
Collaborate 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 innovations through invention disclosures and patent filings.
Work with Marketing and clinicians to define user needs and translate them into testable requirements.
Lead and own Design Verification.
Partner with Manufacturing and Design Quality on transfer to manufacturing and Process Validation (IQ/OQ/PQ).
Manage external testing laboratories, including developing test plans and reports and assessing the impact of design, material, and supplier changes.
Serve as a biological safety subject matter expert and provide strategy.
Lead R&D modules of FDA submissions (PMA, PMA supplements, IDE, and 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 engineering inputs to DFMEA/PFMEA and benefit-risk analysis.
Participate in complaint investigations, root cause analysis, and CAPA, and support FDA inspections and audits as needed.
Partner with Quality and Manufacturing on product and process improvements.
Mentor and develop engineers, including reviewing their protocols, reports, and design decisions.
Champion continuous improvement in engineering efficiency.