R&D Engineer II — Medical Devices (Sustaining & NPD)

Laborie Medical Technologies Corp; Maple Grove (MN); Sur place; USD 85 000 - 125 000; Plein temps

Avantages offerts par ce poste

Paid Time Off

Health Insurance

401k Retirement Plan

Résumé du poste

Laborie Medical Technologies Corp in Minnesota seeks an R&D Engineer II to support PLM, Sustaining and R&D activities for consumable medical devices. You will handle design changes, verification, validation, and manufacturing transfer, collaborating with manufacturing and contract manufacturers.

The role covers design for manufacturability, documentation, and compliance with FDA, ISO, and related standards; travel up to 25% is expected.

Qualifications

• 5+ years R&D or Sustaining Engineer experience in medical devices or regulated FDA/QSR/ISO environments.
• BS degree in Biomedical, Mechanical, Chemical Engineering or related field with 7+ years’ experience in FDA/QSR/ISO environments.
• Strong knowledge of injection molding and assembled consumable medical device technologies and related processes.
• Experience with SolidWorks and CAD design software; creating test fixtures and prototypes.
• Proven experience with design controls, device development standards, FDA regulation, GMP/QSR requirements.
• End-to-end development experience across small and large companies; experience with RCAs and NCMR.

Responsabilités

• Lead new product development and product/process improvements for consumable medical devices.
• Develop product test methods and evaluate requirements for verification and validation.
• Collaborate with manufacturing to qualify equipment vendors.
• Plan and execute IQ/OQ/PQ; conduct risk management and data analysis.
• Develop manufacturing documents and control documentation; review and approve protocols and reports.
• Ensure compliance with EU MDR, ISO, FDA and related regulations.

Connaissances

R&D Engineering

Medical Devices

FDA/QSR ISO

SolidWorks

Design Controls

Root Cause Analysis

Formation

BS Engineering (Biomedical/Mechanical/Chemical)

Outils

CAD Software

Test Fixtures

Description du poste

Laborie Medical Technologies Corp in Minnesota seeks an R&D Engineer II to support PLM, Sustaining and R&D activities for consumable medical devices. You will handle design changes, verification, validation, and manufacturing transfer, collaborating with manufacturing and contract manufacturers.

The role covers design for manufacturability, documentation, and compliance with FDA, ISO, and related standards; travel up to 25% is expected.