One of my top Class III Medical Device clients in Irvine is currently seeking a "Sr. R&D/Manufacturing Engineer" to work on the complete re-design of an existing product for efficiency and cost reduction purposes.
- Create, characterize, and implement new manufacturing processes including leading the design, procurement and qualification of manufacturing equipment and tooling for NPD (new product development) / VE (value engineering) projects.
- Develop solutions to manage complex manufacturing process design, development and validation efforts from early product development through product launch.
- Transfer processes from R&D to Manufacturing using project management, design for manufacturability and cost, process/design excellence, LEAN, ergonomics and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology.
- Development of process specifications which ensure user needs are met
- Perform equipment and process qualifications (TFIQ/IQ/OQ/PQ) as needed.
- Drive incorporation of technical advancements into manufacturing process and technology employed in the manufacture of both existing and new products.
- Work and effectively communicate in a high energy, cross functional team and multiple site environment which includes product design, regulatory, quality, procurement, supply chain, supplier quality and operations to ensure project objectives are met.
- Continuously improve existing processes, manufacturability and sustainability.
- Accountability (including hands on and resourceful) on troubleshooting, problem solving, and escalation of program risk to management when design transfer and scale-up to manufacturing do not work as expected.
- Four (4) years of experience in medical device manufacturing
- Knowledge of Solidworks
- Experience with automation, semi-automation and/or ultrasonic welding/swaging preferred.
- Demonstrated use of process and design excellence methodologies including Six Sigma.
- Knowledge of Design for Manufacturability, and LEAN methodology.
- Ability to develop process requirement/ specifications, collaborate with outside design firms and work with Operations personnel.
- Effective knowledge of design transfer.
- Knowledge of cGMP, EHS guidelines, FDA guidelines and Process Validation.
- Capable of analyzing and solving complex problems through innovative thought and experience.
- Strong verbal/written communication and interpersonal skills including conflict and relationship management.
- A Bachelor's degree in engineering discipline is required; preferably Mechanical, Biomedical, or Manufacturing Engineering.
If you're interested in applying please submit your updated resume in word format! I will be working with the hiring manager to schedule interviews this week!
Sthree US is acting as an Employment Business in relation to this vacancy.