Sr. Mechanical R&D Engineer

Position Description:       

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

Basic Qualifications:        

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

Salary:  $124,500 to $156,000 per year

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

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