- Bachelor's Degree engineering or a related scientific field with 5 years of medical device development experience.
- Medical device industry experience with surgical devices and catheters is highly preferred.
- Experience with key technologies and processes related to the manufacture of medical devices, surgical instruments, catheters, delivery systems, and/or interventional devices is preferred.
- Detail oriented and able to manage multiple work streams.
- Demonstrated use of design excellence methodologies including Six Sigma.
- Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills
- Interacts with external representatives on significant technical matters often requiring coordination between parties.
- Experience utilizing lab equipment (tensile/compression testing, dimensional inspection, fluid flow, air pressure decay, etc.) and adherence to good documentation practice.
- Statistical analysis execution and understanding using Minitab
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Senior Research And Development Engineer - Midvale, United States - enableCV
3 weeks ago
Description
This exciting opportunity as Senior Engineer, Research & Development will support a differentiated business as it is established as a new independent medical device company, enableCV a subsidiary of Edwards Life Sciences. This is an entry level role that will assist in the transition to enableCV, by supporting active programs in commercial production and new product development. EnableCV is based in Midvale, UT and this role will be located on site at the enableCV headquarters. This is a flexible on-site role (3 days minimum in office) which will thrive in a collaborative, start-up like environment.
We are a small tight-knit group of go getters that are willing to wear multiple hats, learn quickly, and be flexible in order to grow and develop this business.
If you have the qualifications (or even if you aren't sure - imposter syndrome is a real thing), want to work hard, and have a great time doing it, we invite you to apply
Essential job functions:
The Senior R&D Engineer will apply sound technical judgement and problem solving to development projects for the existing Edwards' Protection Cannula and Minimally Invasive Surgical device portfolios. Responsibilities to include, but not limited to:
· Support supplier driven design changes through impact assessments and propose and execute design qualification requirements.
· Represent enableCV R&D with contract manufacturers, provide the voice of the user and act as design SME
· Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
· Represent enableCV R&D as design SME on cross functional team for post market surveillance activities.
· Create/update complex design control documents including requirement specs and risk documents
· Evaluate input and form a technical recommendation including designing parts, components and subsystems
· Develop and implement test methods, procedures, test plans, and assist in support of R&D engineering lab
· Assess design documentation for surgical device compliance gaps and formulate and execute plans to mitigate gaps. Prepare technical documentation to support submissions. Respond to notified body questions.
· Support activities related to separation of enableCV from Edwards
Qualifications:
Preferred Qualifications:
Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation, dedication, and people, we're the right company for you. We save lives every day and we love it - join us
