This is a rare opportunity with a dynamic med device start-up involved in a very novel technology that addresses an unmet clinical need. The bonus here is that this is a group of people who have successfully introduced other new products to med device so their knowledge of what it takes to achieve results is unmatched.
The individual must have a 4 year degree in engineering, Chemical preferred, and a minimum of 2 years’ experience in Medical Device manufacturing. Other critical experience includes Continuous Improvement Projects, Test Method Validation, Equipment/Process Validation and CAD experience with SolidWorks.
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
- 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
- Lean/Six Sigma knowledge applied to process improvement across a spectrum of needs
- May lead 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 2+ years, prefer it includes 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