Senior Medical Device R&D Engineer - NPD & Transfer

Laborie; Salt Lake City (UT); Sur place; USD 130 000 - 170 000; Plein temps

Avantages offerts par ce poste

Paid time off

Health, Dental, Vision insurance

401k with company match

Parental Leave

Health Savings Account

Flexible Spending Account

Résumé du poste

Laborie in Utah seeks a Senior R&D Engineer to drive new product development and manufacturing transfer for consumable medical devices. You will design, prototype, select materials, and verify/validate through DFMEA and test methods, ensuring compliance with FDA/QSR and ISO requirements.

You will partner with manufacturing and cross-functional teams to optimize processes, develop test fixtures, and contribute to regulatory submissions while supporting NPD and sustaining activities with a focus

Qualifications

• 8+ years of R&D or Sustaining Engineering in Medical Devices or regulated FDA/QSR/ISO environments
• BS degree in Biomedical, Mechanical, Chemical Engineering or related with 7+ years’ R&D in FDA/QSR/ISO environments
• Experience with injection molding and catheter device technologies; manufacturing transfer

Responsabilités

• Lead new product development and product/process improvements for consumable medical devices.
• Develop verification/validation plans and documentation including IQ/OQ/PQ; perform risk management (dfMEA).
• Collaborate with manufacturing for equipment qualification and process documentation.
• Ensure regulatory compliance with EU MDR, ISO, FDA standards; support life-cycle of products from NPD to sustaining.

Connaissances

Design controls

FDA/QSR compliance

Root Cause Analysis

Statistical analysis

Project planning

Formation

BS in Biomedical/Mechanical/Chemical Eng

MS/PhD in Biomedical/Mechanical/Chemical Eng (preferred)

Outils

SolidWorks

CAD design software

Description du poste

Laborie in Utah seeks a Senior R&D Engineer to drive new product development and manufacturing transfer for consumable medical devices. You will design, prototype, select materials, and verify/validate through DFMEA and test methods, ensuring compliance with FDA/QSR and ISO requirements.

You will partner with manufacturing and cross-functional teams to optimize processes, develop test fixtures, and contribute to regulatory submissions while supporting NPD and sustaining activities with a focus