Senior Product Development Engineer (Medical Devices)

Position Summary

A medical device company is seeking a Senior Product Development Engineer to design and develop precision medical devices used in minimally invasive procedures. These products include highly engineered components requiring extremely tight tolerances and advanced manufacturing and assembly processes.

As part of the R&D organization, this role will work closely with manufacturing engineering, quality, and production teams to support both new product development and improvements to existing products. Responsibilities include leading development activities from concept through commercialization, as well as supporting sustaining engineering initiatives.

The ideal candidate brings strong mechanical engineering fundamentals, experience working within regulated medical device environments, and a structured approach to problem solving.

Responsibilities

• Design and develop precision mechanical components and systems for medical devices

• Conduct engineering analyses, feasibility studies, and concept evaluations for new products and features

• Define product requirements and perform design trade-off analyses to determine optimal solutions

• Investigate product or process issues using structured root cause analysis methods

• Maintain thorough technical documentation in accordance with medical device regulatory requirements

• Collaborate with manufacturing teams on supplier selection, manufacturability, and design transfer

• Support evaluation and implementation of engineering change orders

• Research and evaluate new technologies, materials, and manufacturing techniques

• Manage development activities including project plans, timelines, and resource coordination

• Generate technical drawings for components, assemblies, and system interfaces

• Provide sustaining engineering support for released products

• Participate in a stage-gate product development process following medical device design control principles

• Work closely with cross-functional teams including quality, regulatory, and operations

• Contribute to innovative design concepts and proprietary manufacturing processes

• Support competitive product and technology assessments

Required Skills & Experience

• Proficiency in SolidWorks or similar 3D CAD software

• Experience with finite element analysis (FEA) and GD&T

• Demonstrated ability to apply structured engineering problem-solving methods

• Experience working within regulated medical device environments

• Familiarity with quality systems and design control requirements

• Understanding of manufacturing and assembly processes for precision medical devices

• Experience with sterilization methods and biocompatibility considerations

• Experience supporting process validation activities (IQ/OQ/PQ)

• Knowledge of risk management processes in product development

• Experience with requirements definition, traceability, and verification/validation

• Strong communication and collaboration skills across multidisciplinary teams

Education

• BS in Mechanical Engineering, Physics, or related discipline

• 8+ years of engineering experience

• Advanced degree preferred

Additional Desired Experience

• Experience performing root cause analysis methodologies such as DMAIC

• Strong understanding of mechanics of materials

• Familiarity with fluid or mechanical systems used in medical devices

• Experience working with precision manufacturing or micro-scale components

• Experience collaborating with external suppliers and manufacturing partners

• Ability to fabricate simple tools or fixtures using standard machine shop equipment is a plus