Sr. Mechanical R&D Engineer
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Job Location:
Jacksonville, FL - USA
Yearly Salary:
$ 124500 - 156000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 Bachelors 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: $124500 to $156000 per year
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
