Mechanical Engineer

Mechanical Engineer - Medical Devices

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

We're seeking a 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.

What You'll Do

As a 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.

What We're Looking For

Required Qualifications

+ 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.

Preferred Qualifications

+

Experience with EN60601 testing and medical electrical devices.

+ Strong experience 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.

Why Join Us?

+ 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,…