Job Description

Come 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 Scope

The 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.

Responsibilities

• Subject matter expert and owner of various production processes such as part cleaning, passivation, sterile and non-sterile packaging, labeling, DI water systems, and cleanroom facilities
• Provides manufacturing engineering expertise through detailed process characterization, process documentation, equipment selection, fixture design, and testing
• Manages corrective/preventative actions (CAPA)
• Uses appropriate statistical techniques to develop validation protocols and complete process capability studies
• Leads continuous improvement initiatives and implements Lean tools
• Writes and executes Process Validation protocols and reports
• Performs root cause investigations on product non-conformances
• Prepares new equipment proposals including ROI justification
• Establishes calibration and preventative maintenance specifications
• Manages technical and complex projects and leads cross-functional groups
• Communicates effectively with all levels of the organization

Qualifications

• B.S. Degree in Engineering (Chemical, Mechanical, Manufacturing, Industrial) or equivalent
• 5+ years manufacturing engineering or related experience
• Experience with Process Validation (IQ, OQ, and PQ)
• Experience with selection and commissioning of new production equipment
• Experience with ROI financial analysis and investment justification
• Experience with statistical tools such as control charts, trending, and capability with Minitab or equivalent
• 3D CAD experience in SolidWorks, Creo or similar
• Ability to communicate effectively across departments and with all levels of the organization
• Project management, medical device packaging knowledge, automation experience and prior experience working in a medical device or comparable regulated industry are a plus

Following 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 careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.