Address
Form of workAcumed LLC
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 Manufacturing Engineer (ME) is responsible for supporting the life cycle of Acumed medical devices by meeting operational objectives in production and new product development. This includes developing, integrating, validating and improving production processes and systems. The ME owns continuous improvement of existing processes through the elimination of waste and / or the adoption of new methods of manufacturing. The Manufacturing Engineer is a co-owner of Acumed's Cost of Goods Sold (COGS), On Time Delivery (OTD), and New Product Introduction (NPI) targets. The Manufacturing Engineer supports Acumed's quality-first culture by ensuring Acumed 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. The Manufacturing Engineer must have excellent verbal communication and technical writing skillset with demonstrated experience using analytical methods to solve problems. The Manufacturing Engineer must have a "go and see" mentality and feel comfortable in a shop floor environment.
Responsibilities
- Provides Manufacturing Engineering expertise with specific emphasis on achieving: DFM/A-Design for Manufacturability / Assembly and high product Quality - through detailed process characterization, process documentations, equipment, tools, fixtures, jigs, and qualification.
- Manages all manufacturing details of new product launches
- Develops and implements advanced inspection methods and gaging
- Manages corrective/preventative actions (CAR/SCAR)
- Evaluates inspection frequency considering risk management and process capability
- Uses appropriate statistical techniques to develop validation protocols, complete process capability studies and process validation on processes.
- Actively participate in other team activities to help insure total team success.
- Leads system level Process Improvement (Pi) initiatives and implements Lean tools
- Reviews and approves Process Validation protocols and reports
- Prepares new equipment proposals including ROI justification
- Manages technical operational projects
- Leads cross-functional groups
- Communicates effectively with all levels of the organization
Qualifications
- B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent
- 5+ years Manufacturing Engineering or related experience
- Advanced 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
- Applied understanding of Geometric Dimensioning and Tolerancing (GD&T)
- Add understanding of machining capabilities, CNC programming
- Selection and commissioning of new production equipment
- Applied experience with of Process Validation (IQ, OQ, and PQ) requirements
- Applied experience with statistical tools such as control charts, trending, and capability with Minitab, JMP or equivalent.
- Experience in a regulated manufacturing industry desired
- Knowledge of FDA and ISO 13485 Regulations
- Understanding of Risk Management and experience with tools such as FMEA
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.
