Compliance Specialist V

In addition to supporting the laser program, this role also requires supporting the Radiation safety program by implementing the established Business unit plan, performing X-ray leakage surveys and auditing training and procedures around operation of X-ray generating devices. Minimum qualifications: Bachelor s degree in Physics, Optical Sciences or Engineering, Health Physics, Nuclear Engineering, Nuclear Physics or a related discipline (Direct experience as a Laser Safety Officer (LSO) or Radiation Safety Officer (RSO) in lieu of degree).

Job Role: Compliance Specialist V (Laser Safety Specialist)
Location: Redmond, WA (Onsite)
Duration: 5+ Months

At least 5 years of experience as a laser safety officer (LSO) required

The candidate will primarily support the laser and radiation safety team through lab inspections, evaluating equipment purchase requirements, reviewing R&D experiments, performing various laser exposure calculations and measurements. This role will ensure/establish appropriate area controls for employees working in and around lasers and/or Radiation sources. In addition to supporting the laser program, this role also requires supporting the Radiation safety program by implementing the established Business unit plan, performing X-ray leakage surveys and auditing training and procedures around operation of X-ray generating devices. This role requires the ability to thrive in a dynamic environment and work closely with cross-functional teams, both in research and product.

Responsibilities

• Audit labs for radiation and laser safety compliance
• Analyze safety hazards, assist in creating requirement specifications for hardware containing hazardous elements such as lasers, LEDs, X-ray
• Understand and implement laser and optical safety standards such as FLPPS, ANSI Z1236-1, IEC 60825 and IEC 62471 etc
• Create, review, and approve laser and optical hazard-related SOPs.
• Review and approve work by outside laser service technicians
• Assist in identifying and developing corrective actions and communicating to stake holders
• Conduct power, spectral and temporal measurements for Laser and LED sources
• Implement safety protocols as required by CDPH in the state of CA for X-ray generators
• Perform testing to simulate faults and validate design and Optical safety of equipment
• Ability to communicate and work effectively with all levels of staff.
• Adaptation and innovation when working staff help them establish procedures to ensure compliance with requirements specified by Radiation and Laser Safety programs.
• Cover labs in Sunnyvale, Burlingame, Fremont. Other travel (such as to Redmond WA) as necessary
• Support additional EHS programs as needed (LOTO, lab safety, chemical safety, electrical safety, machine guarding, etc.), especially in cross-functional research and product environments.

Qualifications:
Minimum qualifications:

• Bachelor s degree in Physics, Optical Sciences or Engineering, Health Physics, Nuclear Engineering, Nuclear Physics or a related discipline (Direct experience as a Laser Safety Officer (LSO) or Radiation Safety Officer (RSO) in lieu of degree)
• Experience in safety investigations, either during development process or failure analysis
• Familiarity with multiple types of radiation sources including, x-ray generating machines, lasers and LEDs
• Experience in a technical/engineering role which focused on field testing, failure analysis, reliability, or equivalent.
• Familiarity with ANSI Z136.1 - The American National Standard for the Safe Use of Lasers
• Self-motivated, pro-active, multi-tasking with creative and critical thinking capabilities
• Outstanding communication, report writing and presentation skills

Preferred qualifications:

• Experience working as an LSO / RSO
• Experience working in a hardware research or production environment.
• Ability to influence teams indirectly through timely, accurate, and powerful analysis.
• Experience in safety work associated with laser and LEDs and experience with IEC 60825, IEC 62471 and ANSI Z136.1 compliance.
• Proficiency with FDA/CDRH FLPPS and IEC 60825-1, IEC 62471-1
• Expertise with federal reporting requirements - import/export, initial and model change reports and annual reporting
• Firm understanding of performing laser calculations (MPE, NOHD, NHZ) for various laser types and configurations
• Conducting FMEA and Fault Tree Analysis
• Assist in developing methods for Laser / Optical safety analysis using in-house equipment which reduce cost and improve turnaround time of testing and investigation.
• Experience with RF/EMF safety (FCC and IEEE C95.1) and Ultrasound safety a plus

Must Have skills:

• Proficient with ANSI Z136.1 - The American National Standard for the Safe Use of Lasers
• Familiarity with CDPH X-Ray regulations
• Experience with IEC 60825 and IEC 62471 and Experience with FLPPS (21 CFR 1040.10/11)

Good to have skills:

• Proficiency with FDA/CDRH FLPPS and IEC 60825-1, IEC 62471-1
• Firm understanding of performing laser calculations (MPE, NOHD, NHZ) for various laser types and configurations
• CLSO from BLS