Mechanical Engineer

Senior Mechanical Engineer - Medical Devices

Are you passionate about bringing medical technologies from concept to reality?

We're seeking a Senior Mechanical Engineer to lead the design and development of innovative medical devices that make a meaningful impact on patient care. In this highly visible role, you'll own critical engineering projects from early concept through commercialization, collaborating with cross-functional teams to create products that are safe, effective, manufacturable, and scalable. This is an exciting opportunity to join a growing organization where your technical expertise, creativity, and leadership will directly influence product success and help shape the future of our engineering capabilities.

As a Senior Mechanical Engineer, you'll take ownership of complex product development initiatives while serving as a key technical contributor and partner across the organization.

• Lead mechanical design and product development efforts from concept through design transfer and commercial launch.
• Create innovative engineering solutions that address clinical needs, user requirements, and business objectives.
• Develop 3D CAD models, assemblies, and manufacturing drawings using Solid Works.
• Drive design decisions related to materials, manufacturing processes, reliability, performance, and cost.
• Collaborate closely with Electrical, Software, Quality, Regulatory, Product Management, and Manufacturing teams to deliver integrated medical device solutions.
• Plan and execute prototype builds, testing activities, and design iterations.
• Lead design verification and validation efforts to ensure products meet performance, safety, and regulatory requirements.
• Perform engineering analyses including tolerance stack-ups, risk assessments, and manufacturability reviews.
• Support risk management activities including FMEA and fault-tree analysis.
• Partner with suppliers and manufacturing teams to optimize designs for production and scale-up.
• Support design transfer activities and help ensure smooth product launches.
• Drive continuous product improvements, troubleshooting efforts, and cost-reduction initiatives for existing products.
• Mentor junior engineers and provide technical leadership across project teams.

• Bachelor's or Master's degree in Mechanical Engineering or related discipline.
• 7+ years of mechanical engineering experience, including at least 3 years developing medical devices.
• Proven success leading products from concept through commercialization.
• Advanced Solid Works proficiency, including complex assemblies and detailed drawings.
• Strong understanding of Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Hands-on experience with prototyping, testing, and product development.
• Experience with manufacturing processes such as injection molding, machining, extrusion, and additive manufacturing.
• Knowledge of FDA-regulated product development and applicable IEC/ISO standards.
• Strong problem-solving skills and ability to navigate complex technical challenges.
• Excellent communication and cross-functional collaboration skills.

• Experience with EN60601 testing and medical electrical devices.
• Strong background in design verification and validation activities.
• Experience conducting risk management activities, including FMEA and fault-tree analysis.
• Experience supporting supplier development and qualification efforts.
• Startup, growth-stage, or fast-paced product development experience.
• Demonstrated leadership or mentorship experience.
• Experience working with external manufacturing partners and contract manufacturers.

• Own products from early concept through commercialization.
• Develop life-changing medical technologies that improve patient outcomes.
• Work alongside a highly collaborative team of engineering, quality, regulatory, and manufacturing professionals.
• Influence technical strategy and product direction in a growing organization.
• Enjoy hands-on engineering work alongside high-level design leadership.
• Gain exposure to cutting-edge technologies, rapid development cycles, and multidisciplinary innovation.
• Opportunity to…