Mechanical Design Engineer 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 SolidWorks. 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. 5+ years of mechanical engineering experience, including at least 3 years developing medical devices. Proven success leading products from concept through commercialization. Advanced SolidWorks 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. Don't meet every qualification? We encourage you to apply. We're interested in candidates who are eager to learn, grow, and contribute to our team's success. Job Type & Location This is a Permanent position based out of Saint Paul, MN. Pay and Benefits The pay range for this position is $45.00 - $65.00/hr. Individual compensation offered for this position w