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 is responsible for leading cross-functional initiatives to support product design, new product development, and manufacturing activities for drug-coated catheter combination medical devices. The position plays a critical role in facilitating the transfer of products to manufacturing, driving process development, and ensuring efficient, compliant production in alignment with the company’s quality management system.  Key responsibilities include medical device design and development, drug coating process optimization, project planning, test method development, process validation, design verification and validation (DV&V), data analysis, and technical reporting.

About the Role:

• Responsible for a variety of activities on new product development and product/process improvement for drug combination catheter-based medical devices including design, prototyping, ideation, VOC, animal studies, material selection, verification and validation, maintaining DHF documentation, and design for manufacturability/manufacturing transfer.
• Develop product test methods, define product requirements, research, design, modify, and test medical devices including drug-device combination products.
• Plan, document, and execute design verification and validations. IQ/OQ/PQ, draft protocol/reports, risk management (DFMEA), and statistical data analysis.
• Assess changes in production and the impact to the design of the product and write protocols and reports for verification/validation of products throughout their lifecycle.

Minimum Qualifications:

• 8 years' experience as a R&D Engineer preferably in Medical Devices or other regulated FDA/QSR and ISO environment with a BS degree in Biomedical, Mechanical, Chemical Engineering or related.
• Experience using statistical analysis to analyze data. Minitab experience preferred.
• Proven experience and knowledge of design controls, device design and development standards, FDA regulation, GMP practices and QSR requirements.
• Proven experience managing the end-to-end development cycle, preferably with exposure to both small and large companies

Preferred Qualifications:

• Master’s degree or PhD in Biomedical, Mechanical, Chemical Engineering or related with 6+ years’ experience as a R&D Engineer in a FDA/QSR and ISO environment.
• Knowledge of braided reinforced shaft, catheter design, combination medical devices, working in a controlled environment and injection molding experience
• 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 with SolidWorks, CAD design software, creating/fabricating test fixtures, prototypes and test fixture fabrication.

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

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.