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 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.
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.
- 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 2025 Cigna Healthy Workforce Designation Gold Level
