Senior Engineer, Product Design

Position 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

• 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

• 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 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

• Primarily operates in a professional office environment with standard office equipment.
• This role is largely sedentary but may involve occasional visits to labs or manufacturing facilities.
• Travel is expected to be less than 5% of the time.