Sr. Design Quality Engineer

Medtronic•Boston, MA

1d•Hybrid

About The Position

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.

Requirements

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.
Two (2) years’ experience in Medical device design controls.
Two (2) years’ experience in product risk files.
Two (2) years’ experience in DMAIC.
Two (2) years’ experience in DfR.
Two (2) years’ experience in DfM.
Two (2) years’ experience in Lean Six Sigma.
Two (2) years’ experience in DOE (Design of Experiments).
Two (2) years’ experience in SPC (Statistical Process Control).
Two (2) years’ experience in Variable Gage R & R.
Two (2) years’ experience in ANOVA (analysis of Variance).
Two (2) years’ experience in t-test.
Two (2) years’ experience in regression analysis.
Two (2) years’ experience in Process Capability.
Two (2) years’ experience in Confidence & Tolerance interval analysis and process control.
Two (2) years’ experience in Product and Process risk utilizing d/p FMECA and ISO 14971.
Two (2) years’ experience in New Product Development Life Cycle.
Two (2) years’ experience in QMS process.
Two (2) years’ experience in identifying CTQ (Critical to Quality).
Two (2) years’ experience in FDA 21 CFR Part 820.
Two (2) years’ experience in ISO 13485.
Two (2) years’ experience in GDP (Good Documentation Practices).
Two (2) years’ experience in A3 thinking.
Two (2) years’ experience in PDCA (Plan, Do, Check, Act).
Two (2) years’ experience in 5 Why’s.
Two (2) years’ experience in Ishikawa (Fishbone).
Two (2) years’ experience in CAPA (Corrective and Preventive actions).
Two (2) years’ experience in RCA (Root Cause Analysis).
Two (2) years’ experience in eQMS (electronic quality management system).
Two (2) years’ experience in Minitab.
Two (2) years’ experience in Predictive Complaint Analysis.

Nice To Haves

Knowledge of medical device materials, related processes, and GDP (Good Documentation Practices).
Utilize design capability, value stream and process mapping, and 5S.

Responsibilities

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.
Review protocols and reports to support product validation.
Support Systems NPD Quality team in performing engineering analysis to ensure design quality.
Analyze system, and sub-system risk.
Technical writing.
Resolve high-profile quality issues.
Product improvements for robust design.
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).
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.
Collaborate on predictive complaint analysis.
Conduct post-market product performance reviews to identify and mitigate potential design and quality issues.

Benefits

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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Paid sick time, as required under applicable state law (for temporary employees)