Principal Reliability Engineer

Medtronic • Billerica, MA

3d • Onsite

About The Position

Principal Reliability Engineer for Medtronic, Inc located in Billerica, MA. Responsible for providing quality engineering support to ensure the successful development of Medtronic medical products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Update risk mgmt. documents to reflect updated or changed controls and mitigations, compliance evidence for standards, and risk estimates in response to post-market surveillance. Utilize Mechanical Geometric Dimensioning and Tolerancing (GD&T) and Root Cause Analysis (RCA). Navigate the complexities of government and industry regulations to include FDA 21 CFR Part 820, Current Good Manufacturing Practices (cGMP), ISO 14791, ISO 13485, ISO 9001, ISO 10012, and ISO 17025. Support various regulatory audits for Quality system process documents and records. Coordinate various Corrective & Preventive Actions (CAPA) programs as well as Lean Six Sigma, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP). Utilize risk analysis including Failure Mode Effect Analysis (FMEA), verification and validation (V&V), methodical problem solving, product design, and manufacturing engineering. Leverage Design of Experiments (DOE) and Statistical Analysis. Execute and utilize development protocols to include Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validations (TMV). Responsible for Capital equipment and single-use device design quality and design controls. #LI-DNI. The position will be onsite at the Billerica, MA location 4 days per week. Up to 25% domestic and international travel to various Medtronic project sites in Minneapolis, Minnesota; Boston, MA; Montreal, Canada; and Galway, Ireland. Reason: Project planning, support, and training

Requirements

• Master’s degree in Mechanical or Biomedical Engineering or related engineering field and five (5) years of experience as a quality or manufacturing engineer or related engineering field.
• Experience must include a min. of five (5) years of each of the following: Mechanical GD&T and RCA; FDA 21 CFR Part 820, ISO 14971, ISO 13485, ISO 9001, ISO 10012, and ISO 17025; Supporting regulatory audits for Quality system process documents and records; Lean Six Sigma, GMP, GDP, and CAPA; Risk analysis, FMEA, V&V, methodical problem solving, product design, manufacturing engineering; DOE and statistical analysis; IQ/OQ/PQ, and TMV; Capital equipment and single-use device design quality and design controls.
• Up to 25% domestic and international travel to various Medtronic project sites in Minneapolis, Minnesota; Boston, MA; Montreal, Canada; and Galway, Ireland. Reason: Project planning, support, and training.

Responsibilities

• Providing quality engineering support to ensure the successful development of Medtronic medical products.
• Ensuring design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
• Updating risk mgmt. documents to reflect updated or changed controls and mitigations, compliance evidence for standards, and risk estimates in response to post-market surveillance.
• Utilizing Mechanical Geometric Dimensioning and Tolerancing (GD&T) and Root Cause Analysis (RCA).
• Navigating the complexities of government and industry regulations to include FDA 21 CFR Part 820, Current Good Manufacturing Practices (cGMP), ISO 14791, ISO 13485, ISO 9001, ISO 10012, and ISO 17025.
• Supporting various regulatory audits for Quality system process documents and records.
• Coordinating various Corrective & Preventive Actions (CAPA) programs as well as Lean Six Sigma, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
• Utilizing risk analysis including Failure Mode Effect Analysis (FMEA), verification and validation (V&V), methodical problem solving, product design, and manufacturing engineering.
• Leveraging Design of Experiments (DOE) and Statistical Analysis.
• Executing and utilize development protocols to include Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validations (TMV).
• Responsible for Capital equipment and single-use device design quality and design controls.

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: Principal
• Number of Employees: 5,001-10,000 employees