The purpose of the Manufacturing Engineer III is to assist in manufacturing engineering activities including design transfer, process validation, and design for manufacturability.
Responsibilities:
- Other duties as assigned or required
- Works under moderate supervision. Can work independently or within a team on larger, moderately complex projects or assignments.
- Work with the Design Team to ensure manufacturability and effective design transfer of new products to commercialization
- Develop, document, evaluate, monitor, and improve manufacturing processes
- Review technical drawings such as mechanical design and tolerance stack-ups
- Conduct risk analyses to ensure safe design/processes, write pFMEA documents
- Represents the operations group in projects to ensure manufacturability and serviceability are incorporated into a design plan
- Work closely with vendors and contract manufacturers on technical and operational issues
- Assist with design transfer activities
- Design and create tooling and fixtures as needed for the manufacturing line, including using common rapid prototyping tools, and conventional machining, as well as incorporating basic electronics and programming as needed
Requirements:
- 10 years minimum related work experience
- Four-year engineering degree
- At least 2 years of design transfer experience is a mus
- Biomedical or Mechanical Engineering degree a plus
- Knowledge and experience of DOE
- Knowledge of mechanical drawings including GD&T
- Experience with IQ/OQ/PQ
- Familiarity with thermodynamic, electromechanical, electrical, and chemical systems
- Excellent communication skills with all levels within and outside of the organization
- Previous experience with design transfer to contract manufacturers a plus
- Good documentation skills
- Demonstrated ability to work on problems of a complex scope where analysis of situations or data involves multiple competing factors.
- Experience with system design architecture preferably Python (preferred)
- Medical Device experience a plus
- Experience in Lean/six sigma
- Ability to verbally communicate ideas and issues effectively to other
- Product development lifecycle knowledge is required
- Experience with design transfer and on-going manufacturing of single-use sterile disposables and/or complex electro-mechanical devices
- Understanding of Medical Device design/process control process is desired
- Works well with other engineers in a collaborative, fast-paced goal-driven environment
- Founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
- Solidworks/PDM
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to comprehend and apply mathematic and descriptive statistic principles to the degree required to perform the job based upon job requirements.