Manufacturing Equipment Engineer

2 weeks ago

San Jose, California, United States bioMerieux Inc. Full time
Job Summary

The Associate Principal Manufacturing Equipment Engineer will be responsible for ensuring the optimal performance and reliability of production equipment to maintain employee safety and meet productivity and quality goals. This role will work closely with cross-functional teams to implement and improve manufacturing equipment performance and capability.

Key Responsibilities
  1. Troubleshoot manufacturing equipment to ensure production continuity and document failure analysis and corrective actions in accordance with quality management system and GMP requirements.
  2. Communicate equipment status and repairs progress to production staff in a timely manner.
  3. Diagnose and debug complex optical/electro/mechanical equipment, computer systems, and software solutions.
  4. Lead meetings with cross-functional teams to discuss technical issues, create consensus on the path forward, and ensure issues are resolved.
  5. Identify systemic performance issues, design, and implement effective and sustained mitigations and repairs to enhance overall productivity.
  6. Author equipment troubleshooting procedures and create postmortem reports to document troubleshooting activities, technical findings, and repairs.
  7. Lead hands-on training to other engineers and technicians to improve knowledge and response times.
  8. Drive equipment initiatives to improve product quality, increase part throughput, decrease equipment downtime, and strengthen safety measures.
  9. Lead the cross-functional team to identify new equipment specifications to scale up production capability, upgrade current equipment, and introduce new technology.
  10. Manage internal and/or external equipment builder and spearhead equipment deployment to production line.
  11. Optimize manufacturing equipment during validation and qualification (IQ/OQ/PQ).
  12. Produce Verification/Validation protocols (IQ/OQ/PQ) and related technical reports to support the transfer of new products, processes, and equipment into production.
  13. Lead failure investigations and root cause analyses as they relate to equipment performance.
  14. Oversee the Calibrations and Preventive Maintenance (PM) requirement (procedures and schedule) for all manufacturing equipment, including performing critical PM activities.
  15. Manage critical spare parts inventory to ensure business continuity.
  16. Comply with GMP and GDP guidelines and QMS documentation requirements.
Requirements
  1. Bachelor of Science in mechanical, manufacturing, or biomedical engineering with 7 years of relevant experience or equivalent combination of education and experience to perform at this level.
  2. Minimum 3 years of working in a regulated environment (GMP, ISO, or FDA).
Preferred Qualifications
  1. Proficient with equipment troubleshooting, repairs, validations, and calibration and PM in a regulated environment.
  2. Ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment and ambiguous scope.
  3. Strong project management, oral and written communication, and interpersonal skills.
  4. Proficient with electro-mechanical troubleshooting, pneumatics, system/SW integration, PLC, or vision system.
  5. Ability to read and understand mechanical/pneumatic drawings and electrical schematics.
  6. Experience with 3D design packages (Solidworks, Inventor, Pro E).
  7. Experience with creating BOMs, product specifications, and engineering drawings interpretation (GD&T).
  8. Ability to work under pressure and stringent timelines to recover equipment downtime situations.
  9. Proven ability to quickly diagnose problems through analysis of inspection reports, system log files, system parametric diagnostic data, and other test results, and provide clear and comprehensive solutions.
  10. Hands-on experience with high-volume and fast-paced medical device manufacturing equipment.
  11. Extensive experience with semi-automated equipment troubleshooting, root cause analysis, equipment engineering, failure investigations, and automated assembly equipment.
  12. Proven experience with mechanical design concepts, machinery, and automation: Electrical, Mechanical, and Electromechanical schematics, motors, pumps, vacuum, and hydraulics.
  13. Prior experience with ink jet printers or micro-volume dispense technology would be a plus.
Compensation and Benefits

The estimated salary range for this role based in California is between $122,400 and $152,400. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer. In addition, bioMerieux offers a competitive Total Rewards package that may include:

  • A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options.
  • Company-Provided Life and Accidental Death Insurance.
  • Short and Long-Term Disability Insurance.
  • Retirement Plan including a generous non-discretionary employer contribution and employer match.
  • Adoption Assistance.
  • Wellness Programs.
  • Employee Assistance Program.
  • Commuter Benefits.
  • Various voluntary benefit offerings.
  • Discount programs.
  • Parental leaves.

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