Position Description:
Sr. Development Engineer for Covidien LP (a Medtronic company) in North Haven, CT. Responsible for the Verification Strategy for the 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 to meet defined product requirements and be optimized for manufacturability, reliability, and overall cost to the business. Partner with System Engineering to review and provide input to product requirements. Navigate the complexity of industry regulations to include ISO 13485:2003 and ISO 14971:2007. Coordinate risk activities to contribute to medical device development, related processes, and GMP (Good Manufacturing Practices). Utilize statistical tools, including Minitab. Evaluate medical product/process using techniques such as DOE (Design of Experiment), ANOVA/T-Test, regression analysis, QMS (Quality Mgmt. System), and FDA 21 CFR Part 820. Troubleshoot product-related issues utilizing problem solving techniques and root cause investigation. Author design verification protocols and reports. Review and provide input to test methods/ procedures. Understand the product Performance Qualifications (PQ) process. Relocation assistance is not available for this position. #LI-DNI
Basic Qualifications:
Master’s degree in Mechanical or Biomedical Engineering, Bioengineering or related engineering field and two (2) years of experience as a Systems Engineer or related occupation. Must possess at least two (2) years’ experience with each of the following: Reviewing product requirements; ISO 13485:2003 and ISO 14971:2007; Risk activities and GMP; Statistical tools including Minitab; DOE, ANOVA/T-Test, regression analysis, QMS, and FDA 21 CFR Part 820; Authoring Design Verification protocols and reports; reviewing test methods/procedures; and PQ deliverables.
Salary: $134,000 to $157,200 per year
#LI-DNI
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below: Medtronic benefits and compensation plans
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
