We are looking for several experienced engineers to support a wide variety of medical device development programs. These individuals will play a key role in creating a new world-class medical device design services team at our Plymouth Minnesota location. You will develop medical devices such as trans-catheter heart valve delivery systems, cardiac electrophysiology ablation catheters, complex steerable sheaths, endoscopic biopsy devices, and many more.
Responsibilities & Qualifications
- Support technical interface with customers on a wide variety of device development programs.
- Work with cross-functional teams on all elements of research & development programs, from voice of customer inputs, concept prototyping/testing, verification, and preclinical/clinical studies.
- Design, define and leverage cutting edge technology and intellectual property to optimize design solutions.
- Apply broad engineering knowledge to the design of new products and product enhancements.
- Create rapid prototypes using a variety of automated systems, vendors, support staff, and hands-on builds.
- Support opportunity assessments to select the most clinically valuable future development programs.
- Appropriately scale and optimize best in class engineering and program practices.
- Maintain product files and other relevant documentation to comply with quality standards and regulatory requirements.
- Participate on sustaining engineering and returned product complaint projects.
- A BS engineering or science degree and 7 years of engineering experience.
- Demonstrated ability to support technical interface with customers in device development.
- Independent initiative to be a critical thinker with an appetite for problem solving.
- Collaborative interpersonal skills to project manage and work through design challenges as a team.
- 2 years industry experience in a medical product development and/or manufacturing environment.
- Minimally invasive medical device (preferably catheters) design, development and manufacturing knowledge.
- Experience working with project teams in planning and executing through key milestone phases.
- Familiarity with engineering tools such as DOE and SPC, and ideally experience using Minitab.
- Detail oriented preparation and support of Design Reviews covering:
- ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
- Product requirements, FMEAs, Product & Process Design.
- Design verification and validations protocols and reports.