Medical Device Process Engineer (Onsite, 6mo Contract)

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

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