A global Medical Device company in Irvine, CA is looking for a Sr. Engineer who will manage pilot production builds, planning, tracking and execution of a class III, implantable device at a contract manufacturer.
Must be willing to travel 15%
Skills & Qualifications:
- 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.
- Bachelor's Degree in Engineering or related field with 4+ years related industry experience or Master's Degree or equivalent in Engineering or related field with 3+ years related industry experience required
- Strong background in medical device manufacturing operations
- Proven project management skills
- Excellent communication and interpersonal skills at all levels of employees including upper management, suppliers, and consultants to support professional excellence.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.