Sr. Manufacturing/Process Engineer (Contract)

Ledgent Technology; San Diego (CA); On-site; USD 66,000 - 72,000; Full time

Job summary

Asahi-Intecc USA is seeking a Process Engineer to join our team in California. You will provide engineering support to develop and transfer manufacturing processes for a medical device, driving cost efficiency and productivity in a fast-paced environment.

The role requires hands-on problem solving, Lean Six Sigma experience and strong communication with product development and production teams to ensure successful transfer from pilot to high-volume manufacturing.

Qualifications

• Bachelor degree in Engineering or related field with minimum of 3 years’ experience in a manufacturing engineering or process transfer role.
• Strong communication, organizational, and problem-solving skills.
• Experience in improving manufacturing processes and leading cost efficiency and productivity improvements.
• Knowledge of applicable FDA regulations for medical device industry.

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 solutions for improvement; perform qualification on improvements.
• Develop IOQ, process validation and OQ/PQ protocols.
• Execute IQ, OQ, PQ and validation protocols.
• Utilize lean six sigma 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 transfer and scale-up.
• Ability to manage competing priorities in a fast-paced environment.

Skills

Process engineering

Lean Six Sigma

Problem solving

Communication

Teamwork

Project management

Education

Bachelor's degree in Engineering

Job description

Salary: USD48 - USD52 per hour

• 6-month contract (40 hours/week) - possibility of extension and/or conversion
• Location: 100% Onsite in Tustin
• Pay: $52/hr

Essential Job Functions:

Responsible for providing engineering support to develop and transfer processes of new medical device.

We are looking for a Process Engineer to join our Asahi-Intecc USA team. The successful candidate will have a track record of driving and improving manufacturing processes. The engineer will be a key liaison between our product development team and production team with a focus on delivering quality, cost efficiency and productivity improvements. The ideal candidate will be a strategic thinker, have strong business acumen and have a ‘hands on’ approach to problem solving. They will be comfortable working in a dynamic and fast-paced manufacturing environment and have experience with lean/six sigma practices. This is an exciting opportunity to join a successful, value-driven organization and to make a real impact on the future of Asahi-Intecc USA.

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.

Minimal Qualifications:

The ideal candidate will be a strategic thinker, have strong business acumen and have a ‘hands on’ approach to problem solving and with strict attention to details. They will be comfortable working in a dynamic and fast-paced development and manufacturing environment and prefer to have experience with lean/six sigma practices.

You must have:

• A Bachelor degree in Engineering or related field with minimum of 3 years’ experience in a manufacturing engineering or process transfer role.
• Strong in communication, organizational, and problem-solving skills, and have the ability to work independently and as part of a team.
• Experience in improving manufacturing processes as well as a passion for leading improve manufacturing processes to increase cost efficiency and productivity.
• Knowledge of applicable FDA regulations for medical device industry.
• Sefl-motivated and pro-active in offering ideas and potential projects.