Summary of Functions:
The Manufacturing Engineer will support Production, Project Engineering and Process Engineering functions, as they relate to injection molding and/or assembly projects for the company. Additionally, this position will ensure that all documents or practices follow the Quality Regulatory objectives of MedBio, Inc. The Manufacturing Engineer may be required to assist junior engineers.
Major Duties and Responsibilities:
- Sustain products already in production, addressing scrap issues, specification or safety issues, or potential efficiency improvements, including the response to DCR’s (Document Change Requests) that come from the Production group.
- Use customer-provided drawings or specifications, and consider MedBio quality requirements, to develop accurate and complete product specifications, purchased component specifications, assembly specifications, item masters, and bills of material for all new or transfer products.
- Work with Production Managers, Director of Engineering, Program Managers, Project Engineers, and/or Process Engineers to conceptualize, research, and implement new ideas, processes, and technologies for the advancement of Medbio, Inc. and its customers. The Manufacturing Engineer will provide guidance on quotes or new product developments as necessary, particularly where post-mold processing is required.
- Develop requirements/specifications for any custom fixturing or equipment, and manage procurement, installation, and qualification of that equipment. Create/assemble and file all associated documentation for each fixture.
- Write and execute comprehensive qualifications/validations for any processes that involve something other than non-standard molding, including risk assessment and Process FMEA development.
- Work with internal teams to develop and implement procedures that increase the quality of Medbio-provided services.
- Work well with others in the organization to identify solutions and manage complex or difficult tasks.
- Provide training and/or guidance to junior Manufacturing Engineers, as applicable.
- Provide training and/or insights to any junior engineers in the organization to the betterment of the individual and the company.
- Perform any other related duties as requested by the Production Managers or the Director of Engineering.
The Manufacturing Engineer reports to the Production Manager for daily work priorities. The Manufacturing Engineer reports to the Director of Engineering for product launch support, quoting support, and engineering projects assigned. This position works closely with Supervisors, Technicians, and/or Process Engineers, coordinates with Quality Assurance and Production on inspection or manufacturing activities, and provides project-specific information to Program Managers, Project Engineering, Documentation, Finance, Sales, and Operations as necessary.
Experience and/or Educational Requirements:
- Engineering or relevant degree, or a minimum three (3) years of relevant experience.
- (Prefer) 2-3 years experience in plastic injection molding.
- Good understanding of automation systems and equipment.
- Strong computer skills (Microsoft Office, MS Project).
- Strong product and tool ‘blueprint’ reading skills, with working knowledge of GD&T.
- Strong written/verbal communication skills.
- Good understanding of ISO and FDA regulations and GMPs.
- Proficiency in writing Process FMEAs.
Must be able to work and perform what would be considered standard practices for this type of positions in the industry.