Job DescriptionPosition Summary 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.
Essential Duties & Responsibilities- Project Management: Provide project and technical leadership for device development. Lead small projects with the support of an established Core Team through the medical device product life cycle of development, qualification, manufacturing, and commercial release process. Communicate with external partners to meet project goals. Manage program budget: functional expenses, capital requests, and forecasts. Identify resources needs, costs, program schedule, key milestones, scope, and report the progress to the established plan.
- 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.
Knowledge & Skills- Project Management: Demonstrated experience in leading and managing cross-functional teams to achieve project objectives.
- 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.
Minimum Qualifications, Education & Experience - Must be at least 18 years of age.
- Bachelor's degree in Mechanical Engineering or a related field from an accredited college or university is required.
- Minimum of 7 years of relevant experience in medical device design and development.
Work Environment- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- This role may involve occasional visits to labs or manufacturing facilities.
- Typically requires travel less than 5% of the time.
