About the roleSirtex 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.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 responsibilitiesServe as project lead on one or more concurrent development programs, from user needs and design inputs through design transfer and commercial launchCollaborate closely with Quality, Manufacturing, Regulatory and MarketingOwn Design History File content and lead formal design reviews, ensuring traceability from user needs to verification and validation evidenceDrive concept generation and feasibility work and protect resulting innovations through invention disclosures and patent filingsEngage marketing team and clinicians to define user needs and translate them into testable requirementsLead and own Design VerificationWork 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 changesAct as a subject matter expert for biological safety and provide strategyLead R&D modules of FDA submissions (PMA, PMA supplements, IDE, 510(k)) and EU MDR Technical Documentation, and respond to Regulatory and Notified Body questionsPartner with Quality on design risk management per ISO 14971, owning the engineering inputs to DFMEA/PFMEA and benefit-risk analysisParticipate in complaint investigations, root cause analysis and CAPA, and support FDA inspections and audits when neededPartner with Quality and Manufacturing on product and process improvementsMentor and develop engineers, including technical reviews of their protocols, reports and design decisionsChampion continuous improvement in engineering efficiency
