Manager, Electrical and Controls Engineering

s
Company: Cepheid
Location: Sunnyvale, CA

Apply

Responsibilities

  • Develop high level plans for automation projects including system architecture, risk assessment, schedule and resource planning
  • Provide guidance and technical leadership to the engineering team to design and manufacture automated equipment
  • Create detailed documentation including but not limited to design input requirements, specifications, design of experiments, test protocol, installation /service procedures and validation protocols /reports
  • Manage outside suppliers and contract manufacturers as needed to design and build outsourced tools
  • Establish good engineering /manufacturing disciplines and promote new ways of thinking that will produce best in class automation equipment
  • Evaluate and recommend engineering changes to existing equipment that will ensure maximum productivity
  • Maintain strict compliance with ISO13485, cGMP, QSR and other applicable Quality Management System standards
  • Lead recruiting, retention and development initiatives for the engineering personnel
  • Set and monitor goals for the team that are aligned with the department and corporate needs and encourage growth /development and career paths for the team members
  • Develop and implement policies, standards and procedures for the engineering team
  • 10% Travel

Qualifications
– Bachelor’s degree in Electrical Engineering, Computer Science or related field with 9 – 12 years of combined technical and people management experience, OR
– Master’s degree with 7 – 9 years of combined technical and people management experience

  • Minimum 5 years of hands-on experience with electro-mechanical equipment in a high-volume manufacturing environment
  • Proficient with Allen-Bradley PLC ControlLogix Platform and development tools
  • In-depth knowledge of SCADA/HMI Design, Configuration, Programing, Testing and Troubleshooting
  • Experience with designing and maintaining Vision System used on production equipment (e.g. Cognex /Keyence, etc.)
  • In-depth knowledge of Motion Controllers and PID tuning
  • In-depth knowledge of Computer System Validation methodologies (CSV), 21 CFR Part 11 as well creation of User Requirements Specification and IQ/OQ/PQ protocol/report generation & execution
  • Experience with Commissioning/Decommissioning and Process Transfer
  • Experience with Failure Mode Effect Analysis (FMEA)

– In-depth knowledge of local, national and international Electrical Standards for Industrial Machinery to ensure compliance with UL/CE Marking and Field Labeling requirements. These include but are not limited to current NEC- NFPA 70 & 79, EN 60204, Machinery Directive 2006/42/EC and SEMI S standards

  • Experience in ISO13485 setting and Quality regulations environment
  • Proven track record of successfully driving engineering projects to meet business objectives on time and on budget
  • Demonstrated ability to effectively communicate clear project updates on a regular basis
  • The position requires a high degree of adaptability; creative decision-making; and technical problem-solving abilities

Preferred Requirements:

  • Experience in the Medical Device /Biotech industry
  • Understanding of SQL database
  • Experience with Epson robots
  • knowledge of Rockwell FactoryTalk Metrics
  • Knowledge of Process characterizations, Six Sigma and LEAN