Senior R&D Engineer – Medical Devices (NPD & Sustaining)

Laborie Medical Technologies Corp; Salt Lake City (UT); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, vision

Health Savings Account

401k with company match

Parental Leave

Wellness programs

Industry recognition

Job summary

Laborie Medical Technologies Corp is seeking an R&D Engineer II to contribute to new product development and sustaining activities for consumable medical devices. You will drive design changes, verification/validation, and manufacturing transfer while maintaining DHF documentation and ensuring regulatory compliance.

Key responsibilities include collaborating with manufacturing, defining test methods, and planning IQ/OQ/PQ with risk management.

Qualifications

• 5+ years' experience as a R&D or Sustaining Engineer preferably in Medical Devices or other regulated FDA/QSR and ISO environment.
• BS degree in Biomedical, Mechanical, Chemical Engineering or related with 7+ years’ experience as a R&D Engineer in a FDA/QSR and ISO environment.
• Strong knowledge of injection molding and assembled consumable medical device technologies, processes, and associated requirements and/or experience designing catheters, associated manufacturing processes, and interfacing with contract manufacturers.
• Experience with SolidWorks, CAD design software, creating/fabricating test fixtures, prototypes and test fixture fabrication.
• Proven experience and knowledge of design controls, device design and development standards, FDA regulation, GMP practices and QSR requirements.
• Proven experience in the end-to-end development cycle, preferably with exposure to both small and large companies.
• Experience with Root Cause Analysis tools and methodologies, NCMR disposition and reviews.

Responsibilities

• New product development and product/process improvement for consumable medical devices (Class I, II, and II) including design, prototyping, material selection, verification and validation, maintaining DHF documentation, and design for manufacturability/manufacturing transfer.
• Develop product test methods by studying product requirements; research, design, modify, and test medical devices including combination products.
• Collaborate with manufacturing to identify and qualify equipment vendors.
• Plan, document, and execute design verification and validations. IQ/OQ/PQ, draft protocol/reports, risk management (dFMEA), and statistical data analysis.
• Develop applicable manufacturing documents including MPs, IPs, LHRs, and material handling procedures. Prepare, review, and approve processes, protocols, reports, and other controlled documentation.
• Ensure processes and procedures comply with relevant regulations such as EU MDR, ISO, FDA, etc.
• Participate and aid in the full life cycle of product development – NPD and sustaining – including design changes, usability studies, market needs assessments, design for manufacturability, and process optimizations.
• Travel expectations up to 25%.

Skills

Root Cause Analysis

Design Controls

FDA/QSR knowledge

Lean Six Sigma

Education

BS in Biomedical/Mechanical/Chemical Engineering

Tools

SolidWorks

CAD software

Minitab

Job description

Laborie Medical Technologies Corp is seeking an R&D Engineer II to contribute to new product development and sustaining activities for consumable medical devices. You will drive design changes, verification/validation, and manufacturing transfer while maintaining DHF documentation and ensuring regulatory compliance.

Key responsibilities include collaborating with manufacturing, defining test methods, and planning IQ/OQ/PQ with risk management.