Sr. Mechanical R&D Engineer

Medtronic Inc. • Jacksonville, FL

36d • Hybrid

About The Position

Sr. Mechanical R&D Engineer for Medtronic, Inc located in Jacksonville, FL. Responsible for providing R&D engineering support to ensure the successful development of Medtronic ENT (Ear, Nose & Throat) devices, design transfers, scale-up and ongoing operational support; work with Product Design and Quality control of Class II and Class III medical devices including capital powered equipment and sterile disposable equipment; navigate complex regulations including FDA Quality Systems Regulations (QSR) 21 CFR 820, ISO13485, ISO14971, and EU Medical Device Directive (MDD)/Medical Device Regulations (MDR); responsible for risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis, and Corrective and Preventive Actions (CAPA); apply engineering analysis techniques and tools using Ansys, Minitab, CE Tol, and PTC Creo; coordinate Measurement System Analysis, Design of Experiments (DOE) and Statistical Process Control (SPC), Process Capability and Sampling Techniques; utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP); and design cosmetic molded parts. Create engineering drawings for molded, sheet metal, machined, and off the shelf components using Geometric Dimensioning and Tolerancing (GD&T); and perform Engineering tolerance stack-ups using risk-based techniques and communicate design intent with manufacturers. Position works a hybrid model and will be onsite in Jacksonville, FL -3-4 days per week. #LI-DNI

Requirements

• Bachelor's degree or equivalent in Mechanical or Biomedical Engineering
• Five (5) years of experience as a mechanical design engineer for medical devices or related occupation
• Five (5) years of experience in Product Design and Quality control of Class II and/or Class III medical devices
• Five (5) years of experience in FDA QSR 21 CFR 820, ISO13485, ISO14971, and EU MDD/MDR
• Five (5) years of experience in Risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, and Design Failure Mode Control Analysis
• Five (5) years of experience in Ansys, Minitab, and PTC Creo
• Five (5) years of experience in Measurement System Analysis, DOE, SPC, Process Capability, and Sampling Techniques
• Five (5) years of experience in GMP & GDP
• Five (5) years of experience in Creating engineering drawings for molded, sheet metal, machined, and off the shelf components using GD&T
• Five (5) years of experience in Performing engineering tolerance stack-ups using risk-based techniques

Responsibilities

• R&D engineering support to ensure the successful development of Medtronic ENT (Ear, Nose & Throat) devices, design transfers, scale-up and ongoing operational support
• Work with Product Design and Quality control of Class II and Class III medical devices including capital powered equipment and sterile disposable equipment
• Navigate complex regulations including FDA Quality Systems Regulations (QSR) 21 CFR 820, ISO13485, ISO14971, and EU Medical Device Directive (MDD)/Medical Device Regulations (MDR)
• Responsible for risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis, and Corrective and Preventive Actions (CAPA)
• Apply engineering analysis techniques and tools using Ansys, Minitab, CE Tol, and PTC Creo
• Coordinate Measurement System Analysis, Design of Experiments (DOE) and Statistical Process Control (SPC), Process Capability and Sampling Techniques
• Utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Design cosmetic molded parts
• Create engineering drawings for molded, sheet metal, machined, and off the shelf components using Geometric Dimensioning and Tolerancing (GD&T)
• Perform Engineering tolerance stack-ups using risk-based techniques and communicate design intent with manufacturers

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
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees