About the position
The Senior R&D Engineer will play a critical role in driving the design, development, and implementation of medical devices. This role involves collaborating closely with cross-functional teams-including marketing, commercial, quality, regulatory, and medical groups-to ensure that all product designs meet regulatory standards and customer expectations. As a subject matter expert (SME) in medical device development, the Senior R&D Engineer will lead key projects of significant complexity while applying sound engineering principles, experimental methods, and analytical techniques. The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management.
Responsibilities
- Lead Design Control Activities: Oversee all aspects of design control, including Requirements Management, Design Outputs, Verification & Validation (V&V), Design History File (DHF), and Risk File management.
- Drive Product Development: Plan, design, and implement new products, ensuring compliance with applicable medical device standards.
- Solve Complex Engineering Challenges: Apply experimental, computational, and analytical methods to address technical challenges and ensure product performance.
- Develop and Maintain Technical Documentation: Create and maintain product specifications, requirements, architecture, design, and usability documents.
- Conduct and Oversee Testing: Design and execute exploratory, bench, and V&V testing, developing test protocols and generating comprehensive reports.
- Collaborate with Cross-Functional Teams: Partner with marketing, quality, and regulatory teams to ensure design requirements align with business objectives and regulatory compliance.
- Design & Model Devices: Utilize SolidWorks to create and refine device models for various product lines, with a focus on high-volume disposable medical devices.
- Partner with Suppliers & Customers: Collaborate with customers and suppliers to refine designs and ensure manufacturability, with an emphasis on plastics/polymer engineering and injection molding.
- Mentor & Provide Technical Leadership: Act as a technical consultant, providing guidance on engineering best practices and mentoring junior engineers.
Requirements
- Proven Expertise in Medical Device Design: Extensive hands-on experience developing and improving medical devices, including knowledge of FDA regulations and ISO standards.
- Proficiency in SolidWorks: Strong capability in 3D modeling and design for manufacturability.
- Material & Manufacturing Knowledge: Deep understanding of medical-grade plastics, injection molding principles, and common joining methods.
- Analytical & Problem-Solving Skills: Strong ability to apply statistical methods, including Design of Experiments (DOE), to solve complex engineering problems.
- Strong Communication & Collaboration Skills: Ability to effectively communicate with technical and non-technical stakeholders across departments.
- Knowledge of Engineering Mechanics & Physics: Solid understanding of the principles underlying mechanical design.
- Familiarity with Machine Shop Practices: Understanding of basic machining operations and drafting standards.
Benefits
- Diversity, Equity, and Inclusion commitment
- Equal Opportunity Employer
