Senior Medical Device R&D Engineer - NPD & Manufacturing

Laborie Medical Technologies Corp; Maple Grove (MN); In loco; USD 120.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid Time Off

Medical, Dental, Vision

401k with company match

Parental Leave

Wellness programs

Descrizione del lavoro

Laborie Medical Technologies Corp is seeking an experienced Senior R&D Engineer to lead design and development of drug-coated catheter combination medical devices. You will drive new product development, design verification/validation, and manufacturing transfer while ensuring compliance with QSR/ISO and regulatory requirements.

This role requires 8+ years in R&D/sustaining engineering within regulated medical device environments, expertise in injection molding, and strong data analysis skills.

Competenze

• BS degree required in Biomedical, Mechanical, Chemical Engineering or related field.
• 8+ years of R&D or sustaining engineering experience in FDA/QSR and ISO environments.
• Strong knowledge of injection molding and consumable medical device technologies.
• Experience with SolidWorks and test fixture design.
• Knowledge of design controls, FDA regulations, GMP and QSR requirements.

Mansioni

• Lead new product development and product/process improvements for consumable medical devices.
• Collaborate with cross-functional teams for design transfer to manufacturing.
• Develop product test methods, verification and validation plans.
• Create and review manufacturing documents and protocols.
• Ensure compliance with EU MDR, ISO, FDA regulations and quality systems.
• Support design changes, usability studies and regulatory submissions.

Conoscenze

Design controls

Root Cause Analysis

Process validation

Statistical analysis

Project planning

Formazione

Bachelor's in Biomedical/Mechanical/Chemical Eng or related

Strumenti

SolidWorks

CAD software

Descrizione del lavoro

Laborie Medical Technologies Corp is seeking an experienced Senior R&D Engineer to lead design and development of drug-coated catheter combination medical devices. You will drive new product development, design verification/validation, and manufacturing transfer while ensuring compliance with QSR/ISO and regulatory requirements.

This role requires 8+ years in R&D/sustaining engineering within regulated medical device environments, expertise in injection molding, and strong data analysis skills.