Sr. Design Quality Engineer

Position Description:       

Sr. Design Quality Engineer for Covidien, LP (a Medtronic company), Perform Quality engineering activities in support of new product development. Work cross-functionally to review requirements and identify and assess product risks, and mitigation strategies, as well as review protocols and reports to support product validation. Support Systems NPD Quality team in performing engineering analysis to ensure design quality, analyzing system, and sub-system risk, technical writing, resolving high-profile quality issues, and product improvements for robust design. Utilize Medical device design controls, product risk files, and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC), Design for Reliability (DfR) and Design for Manufacturing (DfM). Utilize DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R, ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, Confidence & Tolerance interval analysis and process control. Evaluate products and process risks using d/p Failure Mode, Effects, and Criticality Analysis (FMECA), utilizing ISO 14971. Navigate New Product Development Life Cycle. Leverage QMS (Quality Mgmt. System) processes including CTQ (Critical to Quality) and knowledge of FDA 21 CFR part 820 ISO 13485:2003 medical device materials, related processes, and GDP (Good Documentation Practices). Utilize design capability, value stream and process mapping, and 5S. Troubleshoot production and other issues utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s and Ishikawa (Fishbone). Leverage Corrective and Preventive actions (CAPA) with use of RCA (Root Cause Analysis) to solve problems, document conditions and create solutions to avoid future problems. Leverage statistical software including (electronic quality mgmt. system) eQMS and Minitab. Collaborate on predictive complaint analysis and conduct post-market product performance reviews to identify and mitigate potential design and quality issues. Relocation assistance is not available for this position. Position works a hybrid model and will be onsite in Boston, MA–4 days per week. #LI-DNI

Basic Qualifications:        

Masters’ Degree in Mechanical, Biomedical or  Bio-Engineering or related engineering field and two (2) years of experience as a product development engineer, quality engineer or related occupation in quality engineering or product development engineering or Bachelor’s degree in Mechanical, Biomedical or  Bio-Engineering or related engineering field and five (5) years of experience as a product development engineer, quality engineer or related occupation in quality engineering or product development engineering. Must possess two (2) years’ experience in each of the following: Medical device design controls, product risk files, DMAIC, DfR , DfM, and Lean Six Sigma;  DOE, SPC, Variable Gage R & R, ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, Confidence & Tolerance interval analysis and process control;  Product and Process risk utilizing d/p FMECA and ISO 14971; New Product Development Life Cycle; QMS process, identify CTQ, FDA 21 CFR Part 820, ISO 13485 and GDP; A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s and Ishikawa (Fishbone);  CAPA  and RCA; eQMS and Minitab; and Predictive Complaint Analysis.

Salary:  $136,600 to $145,200 per year

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