Senior Manufacturing Engineer for Certification jobs in United States
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Sigray, Inc. · 1 month ago

Senior Manufacturing Engineer for Certification

positionBenicia, CA
timeFull-time
remoteOnsite
seniorityMid, Senior Level
date3+ years exp

Sigray, 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
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H1B Sponsor Likelynote

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

CE marking complianceSEMI S2/S8 complianceCompliance documentationEngineering drawings interpretationProject managementMultidisciplinary teamworkISO 12100 knowledgeInternational certification agenciesSemiconductor backgroundX-ray systems familiarityCommunication skillsIndependent work

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.

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Sigray, Inc.
dateFounded in 2013
location
Concord, California, USA
people-size51-200 employees
web-link
https://www.sigray.com/

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 Stage
Total Funding
$1.15M
Key Investors
US Department of EnergyNational Science Foundation
2024-01-09Grant· $0.25M
2016-02-08Grant· $0.75M
2014-12-05Grant· $0.15M

Recent News

Law360
Zeiss Secures $785K In X-Ray Patent Trial Against Sigray
2025-09-12
Google Patent
X-ray detector system with at least two stacked flat Bragg diffractors
2025-05-04
Google Patent
SEQUENTIAL WAVELENGTH-DISPERSIVE X-RAY SPECTROMETER
2025-05-04
Company data provided by crunchbase