Process Engineer- Medical Devices

No C2C or 3rd Party Candidates will NOT be considered

Candidates with a Pharma or Chemical background will not be a fit

Must work 100% onsite in Tustin, CA

This a 6+ month contract; most likely being extended after months

Target pay is $40-$48 per hour W2

***Ideally 2-5 years of experience***

Looking for candidates ideally with Catheter experience but not a must have; looking for someone who has experience with SolidWorks, 3D Models, Process Development.

Key requirements.

- Contribute as part of a product development team to transfer pilot processes to high volume site.
- Develop and improve manufacturing processes to improve cost and productivity.
- Identify, troubleshoot, and resolve any production scale-up issues on design and process.
- Perform investigations and plan/execute matrix experiments to identify solution for improvement. Perform qualification on improvements.
- Develop equipment IOQ, process validation and operational qualification protocols.
- Execute equipment IQ, OQ, PQ and validation protocols.
- Utilize lean six sigma and related practices to streamline production processes.
- Maintain and update engineering documents and records.
- Work with suppliers to resolve material quality issues.
- Design fixtures to improve process output and product quality.
- Coordinate with other departments to ensure effective execution of the transfer and scale-up.
- Ability to manage competing priorities in a fast-paced environment.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.