Position Description:

Systems Engineer for Medtronic, Inc located in Boxborough, MA. Develop and evaluate designs which meet defined product requirements and that are optimized for manufacturability, reliability, and overall cost to the business; utilize DMAIC (Define, Measure, Analyze, Improve, and Control) or DRM (Design, Reliability, and Manufacturability) methodology and Six Sigma to suggest design or manufacturing process improvement;  navigate the complexity of industry regulations to include ISO 13485:2003, ISO 14971:2007 and IEC 60601-1; coordinate risk activities to contribute in medical device development, related processes, and GMP (Good Manufacturing Practices); responsible for user interviews, development of user needs and generation of design criteria; coordinate requirement flow-down process and requirement traceability utilizing requirement tool such as Cognition Cockpit (or similar system) and develop the templates for flow-down; provide expertise in manufacturing process development, Equipment Qualification/ Installation Qualification (EQ/IQ) and provide relevant training; utilize statistical tools, including Minitab; evaluate medical product/process using techniques such as DOE (Design of Experiment), Ranging Studies, ANOVA, regression analysis, QMS (Quality Management System), and FDA 21 CFR Part 820; troubleshoot manufacturing or other product-related issues utilizing problem solving techniques, including 5 Why’s and Ishikawa (Fishbone); and address non-conformances in the manufacturing process, investigate root-cause, and disposition plan. Relocation assistance not available. Position works a hybrid model and will be onsite in Boxborough, MA location – 3-4 days per week.

Basic Qualifications:   

Masters’ Degree in Mechanical, Industrial, or Biomedical Engineering, Bioengineering or related engineering field and one (1) year of experience as a systems engineer, R&D engineer, Biomedical engineer or related occupation in medical device product development. Must possess a minimum of one (1) year of experience with each of the following:  DMAIC or DRM methodology, and Six Sigma; ISO 13485, ISO 14971, and IEC 60601-1; User interviews, development of user needs and generation of design criteria; Requirement Flow-down process and requirement traceability; Manufacturing process development and EQ/IQ; DOE, Ranging Studies, ANOVA, and regression analysis; 5 Why’s & Ishikawa (Fishbone); Addressing Non-conformances in design process, investigating root-cause, and disposition plan.*Relocation assistance not available. Position works a hybrid model and will be onsite in Boxborough, MA location – 3-4 days per week.

Salary: $96,300 to $124,800 per year

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