Technician, Product Performance

About the position

This position works out of our Sylmar, CA location in the CRM Division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.

Responsibilities

• Performs more complex analytical tests (electrical and mechanical) required for trouble shooting to component level to determine failure mechanism on product returned from the field for analysis
• Document nonconformances as appropriate.
• Monitor and/or perform calibration and maintenance of all test equipment and fixtures.
• Initiate related documentation changes.
• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
• Collect data, summarize, and document test results.
• Works with a computer (Microsoft applications such as word, excel, outlook), microscope and variety of diagnostic and test equipments such as oscilloscope, signal generators, multimeters, etc.
• Assist with the selection, installation and programming of precision measuring equipment.
• Create and maintain control plans for products and processes.
• Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements

• High School Diploma / GED
• Technical Diploma (± 12 years) preferred.
• 2-4 years experience.
• Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
• Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design.
• Training in blueprint reading and experience with sampling techniques.
• Good communication and computer skills, including data analysis and report writing skills.
• Prior medical device experience preferred.
• ASQ CQT certification or equivalent preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice-to-haves

• Prior medical device experience preferred.
• ASQ CQT certification or equivalent preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
• A fast-paced work environment where your safety is our priority.
• Training and career development, with onboarding programs for new employees and tuition assistance.
• Financial security through competitive compensation, incentives and retirement plans.
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs.
• Paid time off.
• 401(k) retirement savings with a generous company match.
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities.