Senior Project Engineer - Automation
Medtronic
Position Description:
Leverage cross functional groups to evaluate, develop and coordinate projects for new product development and ongoing lifecycle mgmt. of products, processes and therapies. Monitor projects from initiation through delivery. Assess project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals. Develop and maintain a project plans with site leadership via MS project & Project Online. Work with FDA (QSR) Quality System Regulation, EU MDR (2017/745), 21 CFR Part 820, ISO 13485, and ISO 14971. Conduct, coordinate and aid in formal Process Validations Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV), DOE (Design of Experiments) and PPAPs. Participate in Design for Manufacturing and Assembly (DFMA), Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA) activities assuring that production processes & equipment are taken into consideration. Responsible for continuous improvements in overall product quality and cost by demonstrating an understanding in lean and six sigma. Navigate the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP). Preparing and managing FDA 510(k) submissions, ensuring regulatory compliance for medical devices from development through market clearance. Integrate PDWare resource tracking and planning application to support resource project allocations. Coordinate Engineering changes notices using AGILE or similar QMS, Bill of Materials (BOM) creation, SPAC system, and general Enterprise Resource Planning (ERP) support. Relocation assistance not available for this position. #LI-DNI
Basic Qualifications:
Master’s Degree in Mechanical, Industrial, Biomedical Engineering or Engineering Management or related engineering field and two (2) years of experience as a project or manufacturing engineer or related occupation in automation engineering or a Bachelors Degree Mechanical, Industrial, Biomedical Engineering or Engineering Management or related engineering field and five (5) years of experience as a project or manufacturing engineer or related occupation in automation engineering. Must possess at least two (2) years’ experience with each of the following: MS Project and Project Online; FDA QSR, EU MDR (2017/745), MDR 21 CFR Part 820, ISO 13485 and ISO 14971; IQ, OQ, PQ, Gage R&R, TMV, DOE and PPAPs; DFMA, DFMEA and PFMEA; Lean and Six Sigma; GMP and GDP; FDA 510(k) Regulatory Submission; and AGILE (QMS) and ERP system.
Salary: $120,000 to $150,000 per year
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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