In this role as an Engineer 1 – Process Development you will support development of new manufacturing processes. Assist lead engineers in defining processing or handling equipment requirements and specifications, and review processing techniques for the manufacture of new products to decrease cost, improve throughput, and improve overall quality for commercial product lines.
- Train manufacturing personnel.
- Hands on investigation and troubleshoot manufacturing issues.
- Maintain simple project timelines and provides updates and feedback to project leadership.
- Plans and performs Design of Experiments (DOE) to determine optimal processing methods and formulation
- Confers with team to gain decisions with management, R&D, engineering, and other staff regarding manufacturing, formulations, process requirements and capabilities.
- Confers with vendors to determine basic product specifications and arrange for purchase of small equipment, materials, fixtures, and/or parts.
- Evaluates products according to specifications and quality standards
- Applies statistical methods to estimate future manufacturing requirements, production and field performance data to identify issues and opportunities for improvements.
- Participate in design control meetings and support the development, writing and releasing of manufacturing documentation. Support validation IQ/OQ/PQ protocols, test protocols, and test method validations. Execute provided protocols and write reports to ensure equipment/processes meet part/assembly specifications and regulatory requirements.
- Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
- Ability to run self-directed projects, maintain timelines, stay organized, and balance multiple activities in a fast-paced environment
- Excellent communication (written and verbal) and personal interaction skills
- M.S. degree in Bioengineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field.
- 1-2 years’ experience in medical device or a related industry, or
- Typically requires a B.S. in Bioengineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field.
- Ambition to work in the medical device field
Vacancy Type: Full Time
Job Location: San Diego, CA, US
Application Deadline: N/A