Senior Manufacturing Engineer for Certification

Sigray, Inc. is seeking a driven and detail-oriented Manufacturing Engineer wih EE and/or ME expertise to join our engineering team and lead the certification and regulatory compliance of our innovative X-ray analytical instrumentation. This role is critical for ensuring our products meet global safety standards including CE marking and SEMI S2/S8 compliance, enabling international deployment and customer satisfaction.

As a key team member, you will collaborate across mechanical, electrical, and software engineering teams to integrate safety and compliance into the product lifecycle. You will manage all stages of the certification process—gap assessments, documentation, testing coordination, and technical file preparation—and interface with third-party regulatory agencies and labs.

The Ideal Candidate Will:

• 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

Skills

• 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.)
• Ideally, some familiarity with X-ray systems, radiation shielding, and interlock safety requirements
• 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

Qualifications

• 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

Additional Skills of Interest

• 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

Compensation commensurate with experience
, with stock options and generous benefits

About Sigray

Sigray is a rapidly growing business based in Benicia, CA, that manufactures X-ray sources, optics, and systems. The X-ray systems include X-ray spectroscopy, microfluorescence, and nano- and micro-computed tomography, as well as several unreleased instruments under active development. Sigray's products are shipped worldwide to the leading laboratories worldwide at universities and corporations for research purposes.

The company's culture is dynamic and R&D focused. This is an excellent opportunity to work in a rapidly growing, dynamic company under the guidance and mentorship of leading experts in the X-ray instrumentation field.