Sr. Development Engineer

Medtronic • North Haven, CT

9h • $134,000 - $157,200 • Onsite

About The Position

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 NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210

Requirements

• 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

Responsibilities

• 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

Benefits

• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
• paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level