Manufacturing Engineer with skills including: SPC, FMEA’s, DOE’s, & ISO13485
This position is an excellent opportunity for the right candidate to assist efforts to achieve and maintain the medical device ISO standard. The candidate must be skilled in advanced manufacturing engineering skills and work as a team member to achieve rigorous processes and methods
The candidate is expected to work with Engineering with development of Process Flows, PFMEA activities, documenting Work Instructions and developing robust validation methods. The candidate will support these activities by, conducting DOE’s, process audits, establishing process standards, creating IQ, OQ, and PQ validation documents and maintaining other necessary documents and records to adhere to the ISO13485 requirements.
The candidate will provide expertise in the area of engineering, process and equipment improvement, working with Quality/Sales and Production, and developing a complete set of processes and production documents to manufacture devices in production volumes and sustainably maintain our high quality standards.
Key areas of responsibility will be to:
- Product & Process Transitions: Pre-production volumes to Clinical Trial/Validation Scale Manufacturing (LVM) to High Volume production environment.
- Full Documentation of the Manufacturing Processes
- Owner of the Validation Process – IQ, OQ, PQ
- Creating/Developing/maintaining Manufacturing Instructions
- Owner of Process Flows
- Collaborate with staff for development of pFMEA’s, owner of activities to reduce risk
- Identifying ways to reduce production costs and reduce cycle times
- Collaborate with staff for design/implantation and testing automation systems
- Design and conduct DOE’s
- Train production staff
- Internal Auditor for ISO13485 system
To be considered for this exciting opportunity the candidate must be able to demonstrate a background in new product development and have strong mechanical engineering and statistical data interpretation skills. The candidate will need to have a functional understanding of GD&T, measurement methods, and conducting appropriate Design of Experiments. The candidate should possess a experience in SPC and other statistical analysis (GRR, Equivalence, Attribute Agreement). SME Certification as a CME, ASQ Certification as a CQE or a 6-Sigma Black (or Green) Belt is a plus.
The following experience is desired:
- Degree in Mechanical Engineering (or a related subject)
- Minimum five years’ experience in a manufacturing environment
- Able to work within or lead a team
- Working within ISO13485 Quality Management Systems
- Computer literacy including a good knowledge of Minitab, Excel, Visio and Power Point.
Must have Medical Device industry experience
Geometric Dimensioning And Tolerancing
Six Sigma Methodology