1 Edwards Way Irvine, CA 92614 | Contract
The role will be a part of the newly created Pilot Operations group, supporting the Delivery System Network with visibility to several new products across multiple business units.
Pilot Operations supports the introduction of new products through commercialization. It is a fast paced group looking to introduce more manufacturability upstream in product design lifecycle, while harmonizing best practices across several product development teams, with the ultimate goal of a smooth transfer to a commercial site outside Irvine.
Duties Will Include:
- Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and company' s systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
- Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
- Develop, update, and maintain technical content of risk management files.
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Train, coach, and guide lower level employees on routine procedures.
- Proven expertise in usage of MS Office Suite; CAD experience preferred.
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
- Working knowledge and understanding of statistical techniques.
- Previous experience working with lab/industrial equipment required.
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Strong problem-solving, organizational, analytical and critical thinking skills.
- Substantial understanding of processes and equipment used in assigned work
- Good leadership skills and ability to influence change.
- Knowledge of and adherence to Quality systems.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast paced environment.
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
- Bachelor' s Degree in Engineering or related field with 4 years of related industry experience or Master' s Degree in Engineering or related field with 3 years of related industry experience or Ph.D. in Engineering or related field with no experience.
- CQE (Certified Quality Engineer) is preferred.