Sr. R&D Engineer

Position Description: Provide R&D and quality engineering support to ensure the successful development of Medtronic Neurovascular devices, design transfers, scale-up and ongoing operational support; work with Design and Quality control of Class II and Class III medical devices (bare-metal or coated stents and stent delivery system device design, process development and manufacturing); navigate complex regulations including FDA QSR, CFR 820, ISO13485, ISO14971, IS020417, ISO 15223-1, ASTM F2503 and EU Medical Device Directive; responsible for R&D product Labeling design and development for new product launches, new market expansion, and sustaining products, Supplier activities including part qualifications, Corrective and Preventive action (CAPA), risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis; analyze Post-market surveillance data, investigate and respond to complaints; coordinate Measurement System Analysis, Gage R&R and Test Method validations (TMV); Product Life Cycle Management, utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). #LI-DNI NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210 Basic Qualifications: Requires a Master’s degree in Technology Management or Mechanical, Industrial, Biomedical or Electronics Engineering and two (2) years of experience as an R&D engineer, manufacturing engineer, or related occupation in R&D engineering or manufacturing engineering. Must possess at least two (2) years of experience with each of the following: Product Design, Process Development and Manufacturing and Quality control of Class II and Class III medical devices; FDA QSR, CFR 820, ISO13485, ISO14971, IS020417, ISO 15223-1, ASTM F2503 and EU Medical Device Directive; R&D product labeling design and development for new product launches, new market expansion, and sustaining products, supplier activities including part qualifications, Corrective and Preventive action (CAPA), risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis and Design Failure Mode Control Analysis; analyzing post-market surveillance, investigating and responding to complaints; Measurement System Analysis, Gage R&R and Test Method validations (TMV); and Product Life Cycle Management, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Position permits a hybrid work model and requires onsite work 4 days/week. The position is located at Covidien LP (a Medtronic company), 5290 California Ave., Irvine, CA 92617. Relocation assistance is not available for this position. Salary: $124,000 to $156,000 per year THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com. #LI-DNI 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 matc ... (truncated, view full listing at source)