San Diego, California
US$90000.00 - US$110000.00 per annum
2 months ago
This position provides global cross-functional expertise, guidance, support and governance relative to key Corporate product safety and regulatory compliance requirements and business processes to ensure products are safe, compliant, and conform to customer requirements. The qualified candidate will apply their product safety, electrical engineering, and mechanical engineering expertise as well as knowledge of EMC regulations/testing to help ensure semiconductor manufacturing equipment products conform to applicable regulatory and requirements world-wide.
DUTIES AND RESPONSIBILITIES
* Provide product safety technical guidance and serve as the technical resource in area(s) of expertise.
* Assist in the development of product safety and product stewardship strategies incorporating best industry practices to ensure customer confidence in the safety/compliance of products.
* Lead and/or participate in the development and delivery of awareness training and guidance to product design teams, compliance stakeholders and management concerning interpretation, understanding and complying with regulations/requirements.
* Participate in project specification and requirements reviews and develop relevant safety/compliance test plans.
* Maintain knowledge and application of the global regulations, standards, requirements and certifications that apply to products.
* Assist in the development, review and maintenance of product safety policies, procedures, SOPs and workflows.
* Monitor and perform periodic reviews/audits on selected business processes and products to ensure on-going effectiveness and compliance with product safety and regulatory requirements.
* Review and/or conduct hazard/risk assessments and process hazard assessments (PHAs) relative to proposed, existing or modified product designs.
* Review, conduct or participate in investigations and root cause analysis of product safety-related events.
* Perform, coordinate, and document Hazard Analyses and Risk Assessment of modules, subsystems, and systems.
* Prepare written reports for exposure/hazard/risk assessments and test data as appropriate.
* Develop and execute projects within scope/budget/schedule expectations to achieve required results.
* Document and track corrective actions to resolve safety & compliance issues using 8D methodology.
* Perform and document electrical and mechanical measurements.
* Perform and document industrial hygiene sampling tests or coordinate their completion with outside resources.
* Engage outside resources to establish and manage safety and compliance certification projects.
* Review and edit safety and compliance reports generated by NRTL's and third-party organizations.
* Contribute to product documentation through safety guidance, document reviews, and procedure reviews.
* Assess the safety and compliance consequences of deviations and engineering changes.
* Performs other duties as assigned.
* Minimum of a Bachelor's Degree in an engineering discipline. Electrical Engineer desired.
* Minimum of six (6) years of experience is required. Experience in product safety compliance preferred.
* Solid understanding of electrical and mechanical engineering principles and best practices.
* Working knowledge of EMC regulations and test methodologies applicable to electronic equipment and industrial machinery.
* Awareness of and basic understanding of chemical systems, fluid and gas delivery, chemical safety, global chemical restriction and chemical control laws, Industrial Hygiene.
* Ability to understand and troubleshoot complex technical and regulatory problems, consult with relevant stakeholders, and propose practical solutions.
* Working knowledge of industry standards/regulations applicable to semiconductor equipment products:
SEMI "S" standards (S1, S2, S6, S7, S8, S10, S13, S14, S19, S21, S22, S23, S27, F47 etc.) NFPA 70, 70E & 79 Equipment Field Labeling requirements CE Marking Directives - Machinery, Low Voltage, EMC, Pressure Equipment Machinery safety standards (IEC 60204-1, IEC 60204-33, BS EN ISO 12100, ISO 13849-1, IEC 61010-1, etc.) Product-related laser standards & regulatory requirements - ANSI Z136, IEC 60825-1 & FDA-CDRH Chemical, Environmental and HazCom regulations (REACH, RoHS, WEEE, GHS, TSCA, Calif. Prop 65).
* Ability to translate, statistically analyze data, and effectively report problems through written and/or graphical formats.
* Understanding in safety methodologies (Risk Assessment, Hazard Analysis, FMEA, etc.) and international regulatory schemes: NRTL certifications, CE Mark, CB Scheme, CCC Mark, etc.
* Familiarity with Risk Assessment software (e.g. DesignSafe) or similar tools and knowledge of translating risk assessment results into protective features (guards, interlocks, labels, procedures).
* Knowledge including the fundamentals of electrical safety, mechanical safety, laser safety, and pressurized gas safety.
* Knowledge of OSHA 1910 (LOTO, HazCom, etc.) requirements as they apply to industrial equipment.
* Ability to communicate with and influence design teams and customers.
* Able to work effectively on a cross-functional development team.
* Able to work independently, with limited supervision.
* Ability to support multiple projects at once.
* Ability to understand and apply the principles and practices of product safety to high-tech industrial equipment.
* Familiarity with managing risk while bringing new technology to prototype, pilot, and production stages.