Senior Medical Device Product Development Engineer (Hybrid)

Sirtex Medical; Woburn (MA); Hybride; USD 124 000 - 155 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) matching

Paid time off

Résumé du poste

Sirtex Medical is seeking a Staff Product Development Engineer in the Boston, MA area. This senior individual-contributor role provides technical leadership, owning design controls, verification, validation and regulatory submissions from concept to commercialization and sustaining.

You will lead cross-functional teams, set technical direction, defend evidence for product approvals, and mentor engineers to grow into next-gen technical leads in a hybrid 3 days in office / 2 days remote setup.

Qualifications

• BS in Biomedical or Mechanical engineering with 10+ years of medical device product development experience, or MS with 8+ 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 protocols and reports
• Working command of 21 CFR 820 / QMSR, ISO 13485, ISO 14971 and ISO 10993
• Experience in leading R&D module in FDA PMA, IDE or 510(k) submissions
• Hands-on experience with IEC 62366-1 and FDA HFE guidance including use-related risk analysis, formative studies, critical task identification, and summative testing and reporting will be a plus

Responsabilités

• Serve as project lead on concurrent development programs from user needs through design transfer and launch.
• Collaborate with Quality, Manufacturing, Regulatory and Marketing.
• Own Design History File content and lead design reviews ensuring traceability from needs to evidence.
• Drive concept generation and feasibility; protect innovations via disclosures and patent filings.
• Engage marketing and clinicians to define needs and translate into testable requirements.
• Lead and own Design Verification; support transfer to manufacturing and Process Validation (IQ/OQ/PQ).
• Partner with outside labs for testing and assess impact of changes.
• Act as SME for biological safety and provide strategy.
• Lead R&D modules of FDA submissions (PMA, IDE, 510(k)) and EU MDR Technical Documentation.
• Mentor engineers and drive continuous improvement in engineering efficiency.

Connaissances

Biomedical engineering

Mechanical engineering

Technical leadership

Design controls

Regulatory knowledge

Formation

BS in Biomedical or Mechanical engineering

MS with 8+ years

Outils

SolidWorks

Minitab

JMP

Description du poste

Sirtex Medical is seeking a Staff Product Development Engineer in the Boston, MA area. This senior individual-contributor role provides technical leadership, owning design controls, verification, validation and regulatory submissions from concept to commercialization and sustaining.

You will lead cross-functional teams, set technical direction, defend evidence for product approvals, and mentor engineers to grow into next-gen technical leads in a hybrid 3 days in office / 2 days remote setup.