Senior Product Development Engineer

About the role

Sirtex Medical is hiring a Sr. 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.

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 engineers, including technical reviews of their protocols, reports and design decisions
• Champion continuous improvement in engineering efficiency

Qualifications

• BS degree in one of the above disciplines and 7+ years of medical device product development experience, or a MS with 5+ years
• Demonstrated technical leadership of Class II and/or Class III PMA devices through design controls, design transfer and commercial launch required
• 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 and trade-offs to executive leadership and non-engineering audiences
• Experience in 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 (e.g., SolidWorks) and statistical analysis tools (e.g., Minitab, JMP) required
• 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 will be a plus
• Formal training in statistical problem-solving (such as Six Sigma) preferred
• Track record managing or mentoring engineers, co-ops or interns
• Experience in a growth-stage or startup environment, where wearing multiple hats was the norm