Senior Project Engineer - Automation

Medtronic • North Haven, CT

5d • $120,000 - $150,000

About The Position

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 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

Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior