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- Wayne, NJ 07470
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Sr. Sustaining Engineer, CS - Wayne, NJ
Getinge Group • Wayne, NJ
Posted 10 days ago
Senior Sustaining Engineer- Cardiac Surgery (MAQUET Cardiovascular, LLC; Wayne, NJ) Lead and coordinate efforts for implementation of new product enhancements to address complaints or design issues and to assure regulatory compliance for all products including packaging design. Responsibilities include: coordinate projects and lead junior engineers in finalizing new products from concept to "Design Freeze" approval and working with Manufacturing Engineering and Operations to implement in production; design tools and/or machines of varying types for use in production operations; perform process capability analysis, prioritize process improvement opportunities and innovate and implement process improvements on complex projects; evaluate internal and external technologies to solve complex problems; prepare technical reports, analysis, recommendations and presentations reflecting status and results of ongoing projects on a regular basis; set up new equipment. Ensure its satisfactory operation and instruct others to use the equipment properly; draft protocols and manage all phases of process validations and equipment validations; write procedures and manage all phases of process validations and equipment validations; prepare capital appropriate requests providing required evaluation, analysis and supporting justification; provide ongoing mentoring and technical guidance to engineers, technicians, and functional groups; may supervise other technicians and engineers; and conduct other duties as required.
MINIMUM REQUIREMENTS: Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field plus 5 years of experience in the job offered or 5 years of experience as process engineer, manufacturing engineer, product development engineer or related engineering field. Alternatively, will accept a Bachelor's degree in Mechanical Engineering, Electrical Engineering,Biomedical Engineering or related field plus 7 years of experience in the job offered or 7 years of experience as process engineer, manufacturing engineer, product development engineer or related engineering field.
SPECIAL REQUIREMENTS: Must have: 5 years of experience working in the FDA regulated medical device industry; experience in medical device product/packaging design and manufacturing process development including the design of tools and machines; experience with the medical device design control and product development process (PDP); experience with CAPAs, Root cause investigations, Risk Analysis including design and process FMEAs; experience writing protocol, execution, report generation for Design Verification, Equipment and Process validation, Test Method development and validation; leadership skills and experience managing projects including plan creation, execution, and completion; expertise with statistical analysis including process capability analysis, statistical experiment design using six sigma tools and software like Minitab; and experience with CAD software including Solid Works. (Unless otherwise indicated, MAQUET is seeking the stated ability in the above skills but no specific amount or years of experience in these skills is required.)
Apply by resume only to Angela Marques, Manager, Human Resources/ Employee Relations, 45 Barbour Pond Drive, Wayne, New Jersey 07470,Reference: AM28375.
Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law
MAQUET Cardiovascular, LLC is an Affirmative Action, Equal Opportunity Employer that values the strength that diversity brings to the workplace. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of gender, race/ethnicity, protected veteran status, disability, or other protected group status.