Do work that matters.
At huMannity Medtec, every day brings an opportunity to make an impact.
As a nonprofit medical research and development organization with over 40 years of innovation behind us, we are dedicated to creating life-enhancing technologies that help address unmet healthcare needs.
Our team is made up of curious thinkers, problem solvers, and passionate people who believe their work can make a difference. From research and engineering to operations and support teams, every role helps move our mission forward.
We also believe that doing meaningful work starts with having the time to recharge. That is why we offer a 9/80 schedule, giving employees every other Friday off and 26 additional long weekends each year.
Why our team loves working here:
💙 A mission-driven organization focused on improving lives
⚖️ Work-life balance with our 9/80 schedule (every other Friday off)
🚀 Innovative projects with real-world impact
🤝 A collaborative environment where ideas are welcomed
🍩Weekly team traditions, monthly lunches, and quarterly events that bring us together
Ready to bring your skills to a team making a difference?
Position Summary
We are seeking a highly experienced Senior Mechanical Engineer to support the design and development of implantable medical devices. The ideal candidate will possess extensive experience in mechanical design, detailed engineering documentation, and product development within a regulated medical device environment. This position requires hands-on engineering support for the design of implantable systems and associated components, fixtures, and manufacturing assemblies.
This is a full-time onsite contract position with an expected duration of 6 to 12 months. No travel is required.
Essential Duties and Responsibilities
- Design and develop implantable medical device components and assemblies from concept through production release.
- Create detailed 3D CAD models and engineering drawings using SolidWorks.
- Generate manufacturing drawings and specifications in accordance with ASME Y14.5 GD&T standards.
- Design fixtures, tooling, and test equipment to support manufacturing and product verification activities.
- Develop components utilizing titanium, stainless steel, and other implant-grade materials.
- Select and evaluate epoxies, silicones, adhesives, and related materials for implantable medical device applications.
- Create and maintain assembly procedures, work instructions, and manufacturing documentation.
- Generate assembly drawings, detailed part drawings, bills of materials, and engineering change documentation.
- Prepare engineering plans, protocols, reports, and technical documentation.
- Collaborate with Manufacturing, Quality, Regulatory, and Supply Chain teams.
- Support design verification activities, root cause investigations, and engineering assessments.
- Participate in design reviews and contribute technical expertise throughout the product development lifecycle.
Required Qualifications
- Bachelor of Science (B.S.) degree in Mechanical Engineering or equivalent engineering discipline.
- Minimum of 10 years of mechanical design experience in the medical device industry.
- Minimum of 10 years of direct experience designing implantable medical devices.
- Advanced proficiency with SolidWorks.
- Strong working knowledge of ASME Y14.5 GD&T standards.
- Experience creating detailed manufacturing and assembly drawings.
- Experience designing precision components manufactured from titanium and stainless steel.
- Experience selecting and implementing epoxies, silicones, and adhesive systems in medical device applications.
- Demonstrated experience developing assembly procedures, engineering plans, protocols, and technical reports.
- Excellent written and verbal communication skills.
Regulatory and Quality System Knowledge
- ISO 13485 – Medical Devices Quality Management Systems
- ISO 14708-3 – Active Implantable Medical Devices
- IEC 60601-1 – Medical Electrical Equipment Safety Requirements
- FDA Design Control Requirements (21 CFR Part 820 preferred)
Work Environment
- Full-time onsite position
- Contract duration: 6 to 12 months
- No travel required
- Must be authorized to work in the United States