1. Bachelors Degree in an engineering or technical discipline (or non-technical degree with 2 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).
2. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
3. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.