Principal Manufacturing Engineer
Medtronic
Summary
Principal Manufacturing Engineer for Medtronic, Inc. in Jacksonville, FL. Responsible for coordinating and executing the Medtronic site Verification and Validation (V&V) deliverables, for supplier transfers within the Supplier Optimization group (Transfer Office) under the Operations Innovation team.
Job description
Position Description
Principal Manufacturing Engineer for Medtronic, Inc. in Jacksonville, FL. Responsible for coordinating and executing the Medtronic site Verification and Validation (V&V) deliverables, for supplier transfers within the Supplier Optimization group (Transfer Office) under the Operations Innovation team.
- Assist with defining Quality Impact Level (QIL) of supplier qualified product.
- Design assembly and holding fixtures, coordinate supplier fabrication, and develop protocols, reports, process instructions, preventive maintenance plans, and calibration schedules.
- Navigate the complexities of various government and industry regulations to include FDA 21 CFR part 820, European Union Medical Device Regulation (EU MDR), ISO 13485, ISO 14971, and Good Manufacturing Practices (GMP).
- Responsible for the PPAP (Production Part Approval Process) for supplier provided goods.
- Leverage IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
- Utilize Minitab and associated statistical tools including TMV (Test Method Validation), Capability (Ppk / Tolerance Intervals), and SPC (Statistical Process Control).
- Responsible for providing Control Plans, Process Flow Maps, and PFMEA (Process Failure Mode and Effects Analysis).
- Coordinate the creation and approval of V&V protocols / reports to include top-level assembly or sub-assembly test acceptance criteria, sample sizes based on component/feature criticality, and sampling plans.
- Leverage AGILE, SAP, and ERP system knowledge based on Medtronic Operating Unit/site requirements.
- Execute First Article Inspection activities and summation of results.
- Update all BOM (Bill of Material) structure within the appropriate QMS (Quality Mgmt. System).
Requirements
- Masters' Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a manufacturing or design engineer for medical devices, or Bachelors' Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and seven (7) years of experience as a manufacturing or design engineer for medical devices.
- At least five (5) years' experience with FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, and GMP.
- At least five (5) years' experience with PPAP and IQ/OQ/PQ.
- At least five (5) years' experience with Minitab, TMV, Capability (Ppk / Tolerance Intervals), and SPC.
- At least five (5) years' experience with Control Plan, Process Flow Map, and PFMEA.
- At least five (5) years' experience with creation and approval of V&V protocols, reports for top-level assembly and sub-assembly test acceptance criteria, sample sizes based on component/feature criticality, and sampling plans.
- At least five (5) years' experience with AGILE, SAP, and ERP systems.
- At least five (5) years' experience executing First Article Inspection activities and summation of results.
- At least five (5) years' experience updating BOM structure within QMS.
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- Global Well-being Program
- Incentive Plans
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.