Staff Manufacturing Engineer
Orange County Metro Area, California
The Staff Manufacturing Engineer is needed in one of the largest Medical Device companies. In this role you will lead the design, development, specification and validation of manufacturing equipment and processes within multiple manufacturing cleanrooms. You will also support pilot production, leading ongoing capacity and lean improvements. As the Staff Engineer you will also be involved in process development, equipment procurement and validation for commercial scale up.
- Develop, scale-up, and optimize manufacturing processes for throughput, yield, cost, compliance.
- Manage design, procurement and validation of moderately complex equipment.
- Conduct process/equipment troubleshooting and root cause analysis for different non-conformance reports.
- Design and develop manufacturing processes for new products.
- Create and develop process FMEAs.
- Work closely with the maintenance department to stablish a preventative maintenance and calibration requirement for new equipment.
- Review and develop the process design for facility drawings, P&ID s, equipment documentation.
- Implement improvements in capacity, manufacturability and sustainability of pilot and commercial production line.
- Project leadership of own projects, responsible for schedule development, cross functional collaboration and leading team in execution.
- Develop and execute process validation protocols and create final reports (IQ/OQ/PQ).
- Work in dynamic, cross-functional team environment which includes product development, regulatory, quality and manufacturing to ensure project objectives are met.
- Drive incorporation of technical advancements into the development of manufacturing processes and equipment.
- Maintain technical currency in key disciplines related to processes and equipment in the manufacture of Class III implantable cardiovascular devices.
- Provides updates, strategy recommendations, and plans to management, as needed.
- Anticipates budget needs and quantifies budget to support manufacturing improvement project.
Required Education / Experience / Skills:
- A bachelor's degree in engineering is required; a degree in the Mechanical or Chemical engineering discipline is preferred. Electrical, Manufacturing or Biomedical Engineering degrees, with relevant experience, will also be considered.
- A minimum of 5 years of medical device or pharmaceutical manufacturing engineering experience is required.
- Must have experience leading complex equipment validations within a Class 5 or Class 6 cleanroom environment.
- Ability to develop user requirement specifications, collaborate with Operations personnel and outside design firms to establish efficient manufacturing systems.
- Proficient in project management including developing and maintaining schedules, identifying project risks and mitigation strategies.
- Leading cross functional teams in project execution towards team goals.
- Experienced in technology transfer of equipment and processes.
- Capable of analyzing and solving complex problems through innovative thought and experience.
- Strong communication (written and verbal) and interpersonal skills.
- Possesses ability to handle multiple tasks, with attention of details and effective prioritization.
- Application of lean manufacturing, mistake proofing principals and six sigma methodologies.
- High energy individual who has excellent leadership, teamwork and influencing skills.
- Basic finance required for budget management, business case development and product cost.
- Experience in cGMP guidelines.