At huMannity Medtec we will give you the opportunity to change the lives of millions who are suffering – it’s what we do! We have been at the bleeding edge of medical technology innovation for over 35 years, and we are looking for smart, motivated, and diverse people to help us advance our mission in a truly meaningful way. We will give you what you need to succeed, thrive, and progress, including a tremendous workplace culture featuring a collaborative spirit, fun-loving team, and experienced leadership.
We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year!
The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to support product development and production efforts for all aspects of implantable medical devices and systems; research, plans and designs for mechanical and electromechanical products and systems; coordinates activities involved in fabrication, operation, application, installation, and repair of same.
- Confers with planning and design staff concerning product design and tooling to ensure efficient production methods.
- Specifies, designs, analyzes, simulates, prototypes, builds, tests, documents and releases to manufacturing parts, processes, procedures, assemblies, materials, tooling/fixtures and equipment.
- Organizes, plans, tracks, and closes out design and process issues associated with product performance in development, test, manufacturing, and the field.
- Designs and documents processes and/or tooling/fixtures and equipment such as mechanical/electromechanical, thermal, or hydraulic systems using SolidWorks or other similar programs.
- Supports build plans: enable teams and technicians to meet expectations, execute work orders, track and communicate status, provide updates and solve issues proactively.
- Works closely with teams of engineers and technicians in OPS, R&D, Quality to deliver on projects.
- Often coordinates tasks, technicians and will be responsible for builds and delivering portions of the entire product lifecycle from early phase prototype, characterization, verification and validation and production. Including process transfers to remote sites.
- Bachelor's degree (B.S.) from four-year college or university and 10+ years related experience; or equivalent combination of education and experience. Engineering experience in medical device (or highly regulated industry) design and/or manufacturing is preferred.
- Good understanding of CFR 820 and ISO 13485:2016