Senior Manufacturing Engineer

2 weeks ago

Hillsboro, United States Marmon Holdings, Inc. Full time

Acumed LLCCome join a team where People make the difference As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.Job ScopeThe Senior Manufacturing Engineer is responsible for supporting the life cycle of Acumed medical devices by meeting operational objectives in production. This includes developing, integrating, validating and improving production processes and systems. They own continuous improvement of existing processes through the elimination of waste and/or the adoption of new methods of manufacturing. They are a co-owner of our Cost of Goods Sold (COGS) and On Time Delivery (OTD) targets. They support our quality-first culture by ensuring all processes are aligned to regulated Good Manufacturing Practices (GMPs). The ideal candidate has a passion for manufacturing and can be effective in a quality-first, highly regulated environment. They must have excellent verbal communication and technical writing skillset with demonstrated experience using analytical methods to solve problems. They must have a customer focused, "go and see" mentality and feel comfortable in a shop floor environment. ResponsibilitiesSubject matter expert and owner of various production processes such as part cleaning, passivation, sterile and non-sterile packaging, labeling, DI water systems, and cleanroom facilitiesProvides manufacturing engineering expertise through detailed process characterization, process documentation, equipment selection, fixture design, and testingManages corrective/preventative actions (CAPA)Uses appropriate statistical techniques to develop validation protocols and complete process capability studiesLeads continuous improvement initiatives and implements Lean toolsWrites and executes Process Validation protocols and reportsPerforms root cause investigations on product non-conformancesPrepares new equipment proposals including ROI justificationEstablishes calibration and preventative maintenance specificationsManages technical and complex projects and leads cross-functional groupsCommunicates effectively with all levels of the organizationQualificationsB.S. Degree in Engineering (Chemical, Mechanical, Manufacturing, Industrial) or equivalent5 years manufacturing engineering or related experience Experience with Process Validation (IQ, OQ, and PQ)Experience with selection and commissioning of new production equipmentExperience with ROI financial analysis and investment justificationExperience with statistical tools such as control charts, trending, and capability with Minitab or equivalent3D CAD experience in SolidWorks, Creo or similarAbility to communicate effectively across departments and with all levels of the organizationProject management, medical device packaging knowledge, automation experience and prior experience working in a medical device or comparable regulated industry are a plusFollowing receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careersmarmon.com, and please be sure to include the title and the location of the position for which you are applying.

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