R&D Engineer II
About The Position
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%.
Requirements
- 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 an 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
Nice To Haves
- Experience using statistical analysis to analyze data, Minitab experience preferred
- Experience across full product life cycle – design and development, sustaining, and manufacturing
- 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
Responsibilities
- Providing PLM (product lifecycle management) / Sustaining and R&D support to existing products in our consumables portfolio
- Performing engineering activities in support of new product development and product acquisitions including assembled molded parts and catheter based devices
- Managing design changes, material changes, specification changes, and packaging changes in support of revenue, quality, cost reduction, production, and compliance goals
- 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
- Developing product test methods by studying product requirements; research, design, modify, and test medical devices including combination products
- Collaborating with manufacturing to identify and qualify equipment vendors
- Planning, documenting, and executing design verification and validations (IQ/OQ/PQ)
- Drafting protocols/reports, performing risk management (dFMEA), and statistical data analysis
- Developing applicable manufacturing documents including MPs, IPs, LHRs, and material handling procedures
- Preparing, reviewing, and approving processes, protocols, reports, and other controlled documentation
- Ensuring processes and procedures comply with relevant regulations such as EU MDR, ISO, FDA, etc.
- Participating and aiding 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
