Position Description:

Sr. Systems Engineer-Verification for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for the Verification Strategy for our Surgical Robotics projects in development. Partner with Systems Engineering, Marketing, the design teams, Quality and Project Mgmt. to coordinate meaningful product requirements, a robust design, and ultimately an efficient and effective verification strategy. Develop and evaluate designs which meet defined product requirements and that are optimized for manufacturability, reliability, and overall cost to the business. Partner with System Engineering to develop, review and decompose product requirements (as necessary). Navigate the complexity of industry regulations to include ISO 13485:2003, and ISO 14971:2007. Coordinate risk activities to contribute in medical device development, related processes, and GMP (Good Manufacturing Practices). Utilize statistical tools, including Minitab. Evaluates medical product/process using techniques such as DOE (Design of Experiment), ANOVA/T-Test, regression analysis, QMS (Quality Management System), and FDA 21 CFR Part 820. Troubleshoot product-related issues utilizing problem solving techniques, root cause investigation. Author or review/approve design verification protocols and reports. Review, provide input to, and approve test methods/ procedure. Position works a hybrid model and will be onsite in North Haven, CT – 3 days per week. Relocation assistance not provided.

Basic Qualifications:

Requires a Master’s degree in Mechanical, Biomedical or Bioengineering or related engineering field and two (2) years of experience as a systems engineer or related occupation in systems engineering. Must possess a minimum of two (2) years of experience with each of the following: Product requirement development and review; ISO 13485:2003 and ISO 14971:2007; Risk activities and GMP (Good Manufacturing Practices); Statistical tools including Minitab; DOE (Design of Experiment), ANOVA/T-Test, regression analysis, QMS (Quality Management System), and FDA 21 CFR Part 820; Authoring Design Verification protocols and reports; and authoring/reviewing test methods/procedures.

*Position works a hybrid model and will be onsite in North Haven, CT – 3 days per week. Relocation assistance not provided.

Salary: $124,200 to $157,200 per year

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