Staff R&D/Product Development Engineer
Posted on Apr 17, 2019 by TE Connectivity
TE's Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world's leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.
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+ year's 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, FMEA's, Product & Process Design.
- Design verification and validations protocols and reports.
- Values: Integrity, Accountability,Teamwork, Innovation