Quality Focused Manufacturing Engineer
These opportunities come along once in a career and when they do they demand your attention. Our client is a med device start-up involved in a novel technology that addresses an unmet clinical need and it is a group of people who have successfully introduced other new product concepts to the market with several start-ups.
The individual must have a 4 year degree in engineering, Chemical preferred, and a minimum of 5 years’ experience in Medical Device manufacturing as well as the first three bullets in the Responsibilities listing.
Your core skills need to be a combination of Quality and Manufacturing because this person will be hands-on, directing Test Method Validation, IQ/OQ/PQ, and Verification efforts including but not limited to Quality Plans, inspection methods and testing protocols. Your customers will be internal, involving equipment validations, etc. and external where you will be directly involved with vendors.
You will work cross-functionally to ensure documentation is compliant to the needs of ISO 13485, 21 CFR 820, and FDA regulations; participating in Risk Analysis, Data Collection/Analysis, Controls & Procedures. Still interested? Read on.
RESPONSIBILITIES: (The first three are must haves)
- Test Method Validation ensuring proper definition of devices (e.g. Refractometers, Gas Chromatography) to provide for accurate gauging and inspection resulting in reliable and repetitive results
- Lean/Six Sigma knowledge applied to process improvement across a spectrum of needs
- Hands-on responsibility for IQ/OQ/PQ and the documentation needed during those steps, e.g. DOE, FMEA
- Devise a program to evaluate the precision and accuracy of equipment including establishing and maintaining a Calibration System
- Hands-on involvement with planning and implementation of Audits, both internal and external, ensuring compliance
- Leads CAPA investigations and dispositions NCMR’s
- Supports product design transfers to manufacturing
- May lead and/or participate in Risk Analysis activities at various phases of development, prototyping and commercialization
- Participates in defining the data to be measured and tracked, provides reports on production stability and periodic updates to Risk Management
- Implements quality systems, controls and procedures for an efficient and compliant manufacturing function
- Bachelor’s Degree in Engineering is required; ChE is preferred
- Experience with Med Device manufacturing for 5+ years where 3 of those include clean room manufacturing
- Demonstrable experience drafting and executing protocols concurrent to regulations
- Experienced with CAD systems (e.g. SolidWorks), proficient with the MS Office Suite
- Hands-on experience with machine setup, production, troubleshooting and/or process improvement a plus
- Must be a results oriented quick learner responsive to the needs of the team and with a strong track record of meeting both cost and timeline deadlines
- Experienced working cross-functionally with Research & Development, Operations, and Quality Assurance
- Ability to read blueprints with a good background in GD&T
- Knowledge and experience in test methods including Gage R&R and DOE
- Lean Six Sigma training/certification highly valued