Position offered by enableCV, Inc.

Principal R&D Engineer (#AA-1123): Create, test, and improve the company's Surgical Structural Heart minimally invasive surgical and protection cannula portfolios products by developing complex experiments and tests (including writing and executing protocols), analyzing results, making recommendations, and developing reports based on engineering principles. Support new product development, design improvement, qualification of devices for introduction into new regions, and maintenance of design history files for ensuring continued state of the art performance. Generate work instructions, test methods, engineering models, drawings and prototypes to establish and characterize product and process specifications. Create or update more complex design control documents including requirement specs, and risk documents. Develop and execute engineering project plans. Evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers. Assign research and development support tasks, give instruction to technicians on conducting tests, train technicians and coordinate their work. Evaluate input and form a technical recommendation including designing parts, components, and sub systems. Provide expertise in the optimization of cardiovascular surgical product development. Lead in the improvement, design, and optimization of complex experiments and tests.

Minimum Requirements: Master's degree or equivalent in sciences (Biology, Pharmacy, Medical or Materials), engineering (Biomedical, Industrial, Electrical, or Mechanical), or a related field and 3 years of experience in an engineering role within medical device product or process design, qualification, or validation. Employer will accept a Bachelor's degree or equivalent in sciences (Biology, Pharmacy, Medical or Materials), engineering (Biomedical, Industrial, Electrical, or Mechanical), or a related field and 5 years of progressive experience in an engineering role within medical device product or process design, qualification, or validation in lieu of a Master's degree and 3 years of experience. Work experience to include: 1. Generating and analyzing data using Minitab, including tolerance intervals, hypothesis testing, capability, Gage R&R, and DOE to make pass or fail conclusions. 2. Utilizing visual inspection equipment, calipers, laser micrometers, and tensile test stands. 3. Working with Environmental Health, Safety, and Quality guidelines as they relate to clean room medical device manufacturing. 4. Participating as a member of cross-functional development teams (regulatory, manufacturing, quality, and marketing functions) to brainstorm project strategies. 5. Preparing protocols, reports, and experimental results technical documentation. 6. Preparing and delivering project status presentations to business management. 7. Test equipment verification.

40 hrs./wk.

Salary: $111,550 - $148,519 per year. 

Address of employment: 6967 S River Gate Drive, Suite 104, Midvale, UT 84047.