Senior R&D Engineer

Laborie; Salt Lake City (UT); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Health, Dental, Vision insurance

401k with company match

Parental Leave

Health Savings Account

Flexible Spending Account

Job summary

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

Responsibilities

• 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.

Skills

Design controls

FDA/QSR compliance

Root Cause Analysis

Statistical analysis

Project planning

Education

BS in Biomedical/Mechanical/Chemical Eng

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

Tools

SolidWorks

CAD design software

Job description

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the R&D team, the Senior R&D Engineer will work cross functionally to complete product design, new product development, and manufacturing activities for drug coated catheter combination medical devices. Additionally, this position will facilitate transfer to manufacturing activities, process development, and ensure device manufacturing is conducted efficiently according to the company quality system. The position focuses on medical device design and development, molded parts and assemblies, project planning, test method development, process validation, design verification & validation, analysis and reporting.

About the Role:

• Responsible for activities on 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.
• Assess and define sustaining engineering activities per product line in collaboration with cross functional partners.
• 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% .

Minimum Qualifications:

• 8 + 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 n 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 .

Preferred Qualifications:

• Master’s degree or PhD in Biomedical, Mechanical, Chemical Engineeringor related with 5+ years’ experience as an R&D/Sustaining Engineer in an FDA/QSR and ISO environment.
• Experience using statistical analysis to analyze data, Minitab experience preferred.
• Experience across full product life cycle – design and development, sustaining, and manufacturing .
• Proven successful leadership of cross-function medical device development teams; trained in and uses Design For Six Sigma, Lean Six Sigma, DFM/A and GD&T principles to optimize product development.
• Experience creating 3D models and prints in SolidWorks .
• Leading successful product launches and regulatory submissions .

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events
• Awarded 202 5 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.