Sigray, Inc. · 1 month ago
Senior Manufacturing Engineer for Certification
Benicia, CA
Full-time
Onsite
Mid, Senior Level
3+ years expSigray, Inc. is a rapidly growing business that manufactures X-ray sources and systems. They are seeking a Senior Manufacturing Engineer to lead certification and regulatory compliance efforts for their innovative X-ray analytical instrumentation, ensuring products meet global safety standards.
Health CareMachinery ManufacturingManufacturingMedical Device
Responsibilities
Take ownership of CE marking and SEMI S2/S8 compliance efforts for new and existing products
Maintain detailed technical files and risk assessments to support certifications
Liaise with third-party testing labs to obtain quotations and schedule for on-site testing
Guide design teams on requirements for safety, EMC, and other applicable directives
Assist with audits and customer documentation related to compliance and safety
Qualification
Required
Bachelor's degree in Electrical Engineering, Mechanical Engineering, Physics, or related field
3+ years of experience in product certification or regulatory compliance
Experience with lab-based instrumentation, preferably X-ray or high-voltage systems
Familiarity with certification processes for North America, Europe, and Asia
Deep understanding of international safety standards, including CE Directives (Low Voltage Directive, EMC, RoHS, Machinery Directive, etc.)
SEMI standards, particularly S2 and S8
Experience preparing compliance documentation (DoC, FMEA, Technical Construction Files, etc.)
Strong project management and organizational skills
Ability to interpret engineering drawings, schematics, and product specifications
Excellent verbal and written communication skills
Able to work independently and across multidisciplinary teams
Preferred
Knowledge of ISO 12100 risk assessment methodology
Experience working with international certification agencies (e.g., TUV, SGS, UL)
Background in the semiconductor or analytical instrumentation industries
Ideally, some familiarity with X-ray systems, radiation shielding, and interlock safety requirements
Benefits
Stock options
Generous benefits
Company
Sigray, Inc.
Sigray, Inc.
51-200 employees
H1B Sponsorship
Sigray, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2022 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$1.15MKey Investors
US Department of EnergyNational Science Foundation
2024-01-09Grant· $0.25M
2016-02-08Grant· $0.75M
2014-12-05Grant· $0.15M
Recent News
2025-09-12
2025-05-04
Google Patent
2025-05-04
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