Process Manufacturing Engineer (Medical Device)

Ledgent Technology; Tustin (CA); On-site; USD 65,000 - 92,000; Full time

Job summary

Ledgent Technology in California is seeking a contract Manufacturing/Process Engineer to support transferring pilot processes to a high-volume site in Tustin. The role requires medical device experience and full-time W2 employment; travel to Temecula may occur less than 10%.

You will develop and improve manufacturing processes, perform IOQ/OQ/PQ validations, work with suppliers, apply lean six sigma, and maintain engineering records as part of a cross-functional team through a six-month

Qualifications

• No C2C or 3rd party candidates will be considered, must work on W2.
• Must have Medical Device experience.

Responsibilities

• Contribute as part of a product development team to transfer pilot processes to a high-volume site.
• Develop and improve manufacturing processes to reduce cost and increase productivity.
• Identify, troubleshoot, and resolve production scale-up issues on design and process.
• Plan/execute matrix experiments and qualification improvements.
• Develop IOQ, PQ, and OQ protocols for equipment and processes.
• Execute IQ, OQ, and PQ validation activities.
• Apply lean six sigma and related practices to streamline production.
• Maintain and update engineering documents and records.
• Collaborate with suppliers to resolve material quality issues.
• Design fixtures to improve process output and product quality.
• Coordinate with other departments to ensure successful transfer and scale-up.

Skills

Medical device experience

Job description

No C2C or 3rd party candidates will be considered, must work on W2

100% onsite in Tustin, CA with occasional travel to Temecula, less than 10%

Must have Medical Device experience

Max pay is $57 per hour

This is a 6 month contract that is likely to be extended with the potential of being brought on full time as well

Responsibilities

• 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.