4 days old

Metrology and Maintenance Manager

Berkeley, CA
**Metrology and Maintenance Manager**

Locations:Berkeley, California

Job Family: Research & Development


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Strategy & Innovation

**Requisition Number:** 221023

**Primary Location:** United States-California-Berkeley

**Assignment Category:** Full-time regular

**Experience Level:** Mid level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 15%

**Division Description:**

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the worlds largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthineers

**Job Description:**

Position Overview

The Quality

Metrology/Preventative Maintenance Managerprovides leadership and hands on technical support for medical

device equipment and associated instruments

for our Molecular products located in Berkeley, CA The Manager will

ensure any modification, installation, preventative maintenance; calibration,

operational support, repair, or troubleshooting activity is properly staffed

and supported in compliance with engineering specifications, the Food and Drug

Administration (FDA), and Good Manufacturing Practices (GMP) guidelines. The

individual will be the (SME) for all aspects of the Maintenance and Calibration

programs. This position requires the ability to lead, direct, and grow a

maintenance department, chair meetings, present topics to the leadership team,

provide constant, thorough and professional communication throughout all levels

of the organization.

**Role Responsibilities:**

Manage Preventative

Maintenance/Calibration/Repair Program

Prepare, maintain,

and follow procedures for the maintenance, calibration, and associated

processes to adhere to cGMPs, company, local and state requirements.

+ Support efforts to analyze and communicateperformance against expectations, provide feedback, establish and trackrequired actions to improve performance.

+ Coordinate shutdown activities and schedulingof calibration/PM/repair work.

+ Develop, conduct and document test methodsfor instrument systemstroubleshooting

+ Review Calibration/Maintenance Paperwork andevaluate breakdown and calibration statistics and adjust plans to suit.

+ Increase overall equipment availabilitythrough reduction of breakdowns.

+ Monitor equipment operation and implementcorrective actions for out of specification operation and alarms.

+ Increase overall instrument performancethrough optimization of calibration activities.

+ Monitor instrument calibration results andimplement corrective actions for out of specification conditions.

+ Support Quality Assurance investigations ofbreakdowns and calibration failures.

+ Coordinate equipment and instrument breakdownrepair activities and serve as customer point of contact.

+ Facilitate completion of change controldocumentation.

+ Provide technical troubleshooting support tomechanics/technicians responding to breakdowns.

+ Serve as site owner and subject matter expertof maintenance and calibration systems

+ Prepare and manage shutdown schedules.

+ Develop and implement improvements throughcross-functional interactions.

+ Develop, review, revise, and maintain SOPs forall equipment, utilities and maintenance and calibration processes.

+ Provide day to day supervision includingoversight of work quality.

+ Manage staffing levels to ensure coverage ofmanufacturing and lab operations.

+ Develop training modules; providecoaching/feedback to develop/enhance technical personnel capabilities.

+ Remain current on industry and FDA engineeringstandards and trends.

**Required Skills, Education andCompetencies:**

+ Bachelors Degree in mechanical/electricalengineering

+ Minimum 10 years of experience in medicaldevice or pharmaceutical or similar regulated industry preferred.

+ Minimum 5 years maintenance supervisoryexperience required.

+ Must be proficient in the use of MicrosoftOffice Applications, including Microsoft Project, Word, Excel and SAP.

+ Must be a creative thinker with goodinterpersonal relationship skills, strong project management and processimprovement skills, as well as strong cross-functional teamwork skills.

+ Ability to clearly and concisely expressthoughts in written procedures, protocols, and reports. Ability to writeprocedures that clearly define required tasks. Ability to proofreadothers work for accuracy. Ability to generate presentations/reportsto explain and/or analyze areas of responsibility.

+ Effective oral and written communicationskills, acute attention to detail, excellent time and project managementskills, and the drive to complete projects thoroughly is required, as isthe ability to handle multiple priorities in a fast-changing workenvironment.

+ Comfortable establishing culture ofperformance. Able to effectively delegate while retaining oversight ofimportant tasks.

+ Hands-on ability to isolate problems andidentify root cause of issues.

+ Ability to acquire data, to organize, toanalyze, and reach accurate conclusions.

+ Working knowledge of statistical methods usedto develop metrics.

+ Ability to teach others how to analyze data toidentify trends and establish corrective actions.

+ Understanding of engineering principles as theyapply to facility and production equipment.

+ Understanding of maintenance and calibrationstrategies and techniques. Understanding of Continuous ImprovementPrinciples.

+ Understanding of engineering principles asthey apply to scientific instruments.

+ Experience with calibration systems andmetrology concepts.

+ Detailed knowledge of process control andinstrumentation systems.

+ Knowledge of OSHA requirements andunderstanding of cGMP, GDP, and FDA requirements as they apply toprocessing. Experience with regulatory interaction/auditing.

+ Ability to understand mechanical layouts andelectrical/pneumatic schematics (P&IDs).

**What can Siemens-Healthineersoffer you?**

Full health benefits including medical, dental

and vision available to you on day 1

Matching 401k program

20 Days of PTO + 10 observed holidays

Tuition Reimbursement

Career Advancement

Please visit our career site at http://www.usa.siemens.com/healthineers/careers

**Equal Employment Opportunity Statement**

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

**EEO is the Law**

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


  • Engineering
  • Financial Services
  • Legal
  • Manufacturing / Production
  • Healthcare

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Berkeley, CA

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