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The Santa Clara Site Hardware Test Center is a quality engineering laboratory that provides testing and certification of Agilent products to international standards. As the Senior Product Safety Engineer, you will have responsibility for a wide range of technologies covering LC and GC mass spectrometry, Genomics, Automation Products, and Precision Measurement Lasers.
- Develops and implements programs and processes to ensure that company products are safe, legal, and meet or exceed customer expectations for compliance with national/regional/global regulations.
- Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
- Compiles materials required in submissions, license renewal, and annual registrations and maintains updated information about national/regional/global regulatory requirements.
- Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort, and identifies and mitigates areas of risk.
- Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to customers and/or authorities' requests/inquiries dealing with regulations and product safety compliance.
- Represents the company in external bodies dealing with standards and/or product regulations at the national/regional/global level. May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
Education:
Bachelors or Masters Degree in electrical engineering, mechanical engineering, or related hardware technical discipline.
Experience:
- Ideal applicant will have 8+ years of direct experience or expertise in product safety compliance.
- Thorough understanding of the IEC 61010-1 and associated standards demonstrated by evaluating and testing products against the specified design requirements.
- Translating product safety requirements into design requirements for R&D engineers and providing product safety technical guidance.
- Planning and conducting IEC 61010-1 product safety tests (e.g. hi-pot, touch current, plug discharge, bonding impedance, abnormal conditions, temperatures, accessibility, stability, etc.).
- Writing product safety reports for submittal to third-party safety agencies, including all applicable information and supporting documentation.
- Collecting and submitting required information for various international product compliance registrations, such as those required for CSA, KC, or RCM marks.
What will make you stand out:
- Participating in IECEE SMT/CTF (Supervised Manufacturer Test/Customer's Testing Facilities), Stage 3 program for CB Scheme, or equivalent.
- Experience with the EU Machinery Directive Dir 2006-42-EC.
- Conducting tests and generating test reports per IEC 60825-1 and U.S. 21 CFR Part 1040.10.
- Evaluating and testing multilayer printed wiring boards that contain AC Mains circuits.
- Managing product safety event investigations, including hazard and risk assessment, failure analysis and action plan development.
- Using the risk management process for medical devices (including in vitro diagnostic medical devices) per ISO 14971 and creating risk assessments.
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.