Medtronic Manufacturing Engineer in Danvers 35 Cherry Hill, Massachusetts
Danvers 35 Cherry Hill, Massachusetts, United States
Aug 08, 2022
Manufacturing Engineer for Medtronic, Inc. located in Danvers, MA. Multiple positions available. Responsible for improving manufacturing processes, optimize product performance and reduce manufacturing costs for Deep Brain Stimulation coils. Identify and implement yield improvement actions including yield tracking, root cause investigation and solution implementation. Coordinate engineering activities and present weekly yields to stake holders. Utilize Good Manufacturing Practices (GMP) and ISO13485 requirements for manufacture of medical devices; perform investigation, disposition and corrective action for production issues through the quality system procedures including Non-Conforming Material Review (NCMR) and Corrective and Preventive Actions (CAPA); define and generate Manufacturing Process Instructions, engineering protocols, reports and process risk analysis documents to include Process Failure Mode and Effects Analysis (PFMEA); develop, qualify, validate and release equipment and processes for production purpose either on site or offsite through IQ, OQ, and PQ; and process characterization activities using statistical tools like Minitab to design and analyze Design of Experiments (DOE) and Statistical Process Control (SPC); develop test methods and validation plans to evaluate test method repeatability and stability through equipment qualification and Test Method validation using Gauge RR Studies; utilize CAD software and Solidworks while interpreting complex engineering drawings including advanced geometric dimensioning and tolerancing (GDT) applications for completeness, reliability, manufacturability, inspectability and cost efficiency; and provide inputs to Design For Manufacture Assembly (DFMA) and PFMEA. Characterize processes to determine input and output process parameters. Utilize Design for Manufacturing principals to determine process capability.
Masters degree in Mechanical, Industrial, Biomedical or Plastics Engineering, or related engineering field and 6 months of manufacturing engineering experience in a medical device industry. Must possess 6 months of experience with each of the following: GDT applications and interpretations; IQ, OQ, and PQ under FDA and ISO13485 guidelines; Minitab, DOE, and SPC; DFMA, FMEA and GMP; CAD and Solidworks; and Non-Conforming Material Review and CAPA.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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