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Key Details:
- 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.
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.
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