Senior Project Engineer Automation

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:

Masters 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: $120000 to $150000 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 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