R&D Engineer II

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.

As a key member of the R&D team, the R&D Engineer II will be responsible for providing PLM (product lifecycle management) / Sustaining and R&D support to existing products in our consumables portfolio as well as performing engineering activities in support of new product development and product acquisitions including assembled molded parts and catheter based devices. This includes a wide variety of responsibilities including design changes, material changes, specification changes, packaging changes, in support of revenue, quality, cost reduction, production, and compliance goals.

• 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.
• 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%.

• 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 Solid Works, 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.

• Experience using statistical analysis to analyze data, Minitab experience preferred.
• Experience across full product life cycle – design and development, sustaining, and…