Job Responsibilities and Essential Duties:

Work with other engineers to develop & optimize processes required for new products.\nPrepare protocols and reports for Installation Qualifications (IQ), and Operational Qualifications (OQ), Test Method Validations (TMV), and Performance Qualification (PQ). Execute protocols to complete Installation Qualifications (IQ), and Operational Qualifications (OQ), Test Method Validations (TMV), and Performance Qualification (PQ). Assist with preparation of process risk documentation (pFMEA).\nAssist / Coordinate pilot production / pre-release manufacturing.\nWork closely with Manufacturing to release new processes and equipment into production.\nWork closely with Manufacturing to support new processes and equipment that have been recently released into production.\nAssist with training efforts on new equipment and processes. Assist with creating and implement required documentation including but not limited to; equipment history files, manufacturing procedures, test methods, BOM's, routings, etc.\nResponsible for change orders (ECO/DCO's) required to release and/or update controlled items.\nMaintain compliance to Quality System and regulations for new processes and equipment.\nAssist in special projects as needed. Contribute to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities:

Problem solving / troubleshooting skills.\nExcellent communication skills with the ability to prepare written reports.\nAble to work in a cross functional team environment.\nComputer skills including MS Office Suite (Word, Excel, etc.).\nExperience with developing and optimizing new manufacturing processes preferred.\nExperience with introducing new equipment / processes into production preferred.\nExperience with process control & statistical analysis techniques preferred.

Minimum Requirements:

Bachelor's Degree in Engineering\nMinimum 3 years experience medical device experience

Quality Requirements:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).\nMust have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).\nAttend all required Quality & Compliance training at the specified interval.\nAdopt the \"Beyond Compliance Quality Culture\" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:

Ensures environmental consciousness and safe practices are exhibited in decisions.\nDuties are performed in an office environment and within manufacturing spaces as required. The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Monday-Friday, 8:30am-5pm\n$75,120-$93,900/annually + 4% STIP\n#LI-LG1\n#LI-Hybrid About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at

Getinge:

\nAt Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits\n401k plan with company match\nPaid Time Off\nWellness initiative & Health Assistance Resources\nLife Insurance\nShort and Long Term Disability Benefits\nHealth and Dependent Care Flexible Spending Accounts\nCommuter Benefits\nParental and Caregiver Leave\nTuition Reimbursement Getinge 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. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. 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