Process Engineer- Medical Devices

Ledgent Technology; Tustin (CA); On-site; USD 55,000 - 66,000; Full time

Job summary

Ledgent Technology seeks a Process Engineer- Medical Devices for onsite work in Tustin, CA. This 6+ month contract offers hourly pay between $40 and $48 (W2). Ideal candidates have 2-5 years in a related field and experience with SolidWorks, 3D modeling, and process development.

Responsibilities include transferring pilot processes to high-volume sites, developing and improving manufacturing processes, and executing IQ/OQ/PQ and validation protocols. Onsite only, no C2C or 3rd-party candidates.

Qualifications

• 2-5 years of experience preferred in medical devices or related fields.
• Strong problem-solving and analytical skills.

Responsibilities

• Transfer pilot processes to high-volume site.
• Develop and improve manufacturing processes for cost and productivity.
• Identify, troubleshoot, and resolve production scale-up issues.
• Plan and execute matrix experiments to identify improvements and qualification efforts.
• Develop IOQ, process validation and OQ protocols.
• Execute IQ, OQ, PQ and validation processes.
• Apply lean six sigma methodologies to streamline production.
• Maintain 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 smooth transfer and scale-up.
• Manage competing priorities in a fast-paced environment.

Skills

Catheter experience

Experience with manufacturing

Tools

SolidWorks

3D Modeling

Process Development

Job description

Process Engineer- Medical Devices (JN -082026-428839) Tustin, California

Salary: USD40 - USD48 per hour

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.

Process Engineer- Medical Devices (JN -082026-428839) Tustin, California

Thank you for submitting your application.