Staff Manufacturing Engineer
Orange County Metro Area, California
Job Title: Principal Engineer
Location: Irvine, CA
Exciting opportunity to join a revolutionary, fast growing team at the ground floor in support of the company's valve platform. The Principal Engineer will utilize strong leadership and influencing skills to lead the charge in establishing the manufacturing clean room, and supporting rooms for RESILIA commercial manufacturing and other process development, commercial integration projects under the Global Supply Chain Valve Network.
- Utilize lean manufacturing methodologies, design for manufacturability, process/design excellence, ergonomics and knowledge transfer methodologies to lead the development of the manufacturing process flow, layout and manufacturing systems for optimum efficiency.
- Coordinate with facilities to assure new construction meets manufacturing requirements. In addition, this position will have hands-on involvement in process development, including specifying, procuring and validating new processes and manufacturing equipment.
- Support manufacturing functions, handling multiple projects and leading cross functional project teams.
- Anticipate project spending needs, quantify spending to support budget planning, and manage budget.
Required Education / Skills / Experience:
- A Bachelor's of Science Degree in Engineering is required. A degree in Mechanical, Chemical, Biomedical, Industrial or Manufacturing Engineering is highly preferred. Professional technical certification(s) preferred.
- A minimum of 8 years of experience in leading NPI manufacturing projects within a regulated cleanroom environment is required.
- Medical Device, Pharmaceutical and/or Biotechnology industry experience is highly preferred
- Knowledge of clean room design, construction, qualification, and maintenance of cleanroom environment per ISO 14644 is required.
- Applies engineering methods (e.g., Six Sigma and LEAN methods) for problem solving and continuous process improvement.
- Demonstrate use of process and design excellence methodologies to optimize processes and Operational efficiency.
- Demonstrate use of Design for Manufacturability (DFM), Industrial Engineering and lean experience leading to manufacturing efficiency improvement.
- Knowledge of cGMP, EHS guidelines, FDA guidelines, QSR, FMEA, statistical techniques, Supplier Quality and Process Validation (IQ, OQ, PQ and PPQ).
- Interpersonal skills including problem solving, effective communication, conflict and relationship management.
- Solid project management and team leadership skills to lead cross functional teams toward project goals.
- Able to thrive in a highly collaborative team environment, effective in creative debate and influencing others.
- Must be self-motivated with tangible solid contribution, a calculated assertive risk taker and change agent.
- Software knowledge related statistical tools, project management, CAD, process flow simulation, Microsoft Office suites.