JOB DESCRIPTION
The Senior Product Safety and Compliance Engineer is responsible for ensuring that all products meet applicable safety standards, regulatory requirements, and industry guidelines. This position involves evaluating products for safety and compliance, managing safety certifications, and providing technical leadership in safety engineering throughout the product lifecycle. The role requires a deep understanding of safety principles, regulatory frameworks, and the ability to collaborate with cross-functional teams to maintain compliance and mitigate risks.
The ideal candidate will bring extensive experience in product safety engineering, a proactive approach to risk management, and a strong understanding of global regulatory standards.
Key Responsibilities:
- Product Safety Evaluation:
- Perform detailed safety assessments of products, ensuring compliance with relevant safety standards (e.g., SEMI, IEC, UL, CE, ISO).
- Identify potential safety risks in product designs and recommend modifications to mitigate those risks.
- Collaborate with design and engineering teams to ensure safety is integrated throughout the product development process by defining product safety and compliance requirements and execution of the requirements.
- Compliance Management:
- Ensure products comply with all applicable regulations, standards, and certifications, including environmental and safety-related laws (e.g., RoHS, REACH, FCC, OSHA, etc.).
- Lead efforts to obtain and maintain necessary certifications, including coordinating with third-party testing labs and certification bodies.
- Keep up-to-date with changes in regulations and standards, ensuring the organization is proactive in addressing compliance issues.
- Risk Assessment & Mitigation:
- Conduct hazard and risk assessments on products and systems to identify and resolve potential safety issues.
- Develop and maintain safety documentation, such as hazard analysis, FMEA (Failure Mode and Effects Analysis), and risk mitigation plans.
- Lead root cause analysis for safety incidents or non-compliance issues and implement corrective actions.
- Testing and Validation:
- Develop test protocols and oversee the testing of products to ensure they meet safety and compliance standards.
- Work with quality assurance and testing teams to verify that products perform as expected under all operating conditions.
- Interpret test results and recommend design improvements or corrective actions when necessary.
- Cross-Functional Collaboration:
- Provide technical guidance to engineering teams on safety and compliance issues.
- Attend peer and cross functional design reviews, and provide advice on minimizing Product EHS impacts, and for ensuring compliance with all applicable standards.
- Work closely with product management, manufacturing, quality, and legal teams to ensure all products comply with regulatory and safety requirements.
- Act as a liaison between the company and regulatory agencies or certification bodies.
- Documentation & Reporting:
- Prepare and maintain comprehensive safety and compliance documentation for all products.
- Ensure all necessary reports and documentation are prepared for regulatory submissions and audits.
- Provide regular updates to leadership on product safety issues, certifications, and compliance status.
- Training & Development:
- Provide safety and compliance training to internal teams, including engineering, manufacturing, and quality assurance.
- Mentor and support junior engineers in safety engineering practices and regulatory compliance.
- Participate in the SEMI EHS Standards process, to ensure new revisions to the SEMI standards are value added for all Axcelis engineering teams.
Qualifications:
- Education:
- Bachelor’s degree in Engineering (Electrical, Mechanical, Safety, or a related field).
- Master’s degree or specialized certifications in Product Safety or Compliance are a plus.
- Experience:
- Minimum of 5-8 years of experience in product safety engineering or compliance, with experience in a regulated industry (Semiconductor capital equipment).
- Familiarity with global safety standards, such as SEMI, NFPA, IEC, UL, CE, ISO, RoHS, and other relevant safety and compliance certifications.
- Experience in conducting risk assessments, hazard analysis, and root cause analysis for safety-related issues.
- Skills:
- Strong understanding of regulatory requirements and safety standards.
- Ability to interpret and apply safety regulations and standards to product designs and processes.
- Excellent problem-solving and analytical skills with attention to detail.
- Strong project management skills with experience managing safety or compliance-related projects.
- Excellent written and verbal communication skills, with the ability to communicate technical information clearly.
- Experience with radiation emitting equipment
- Experience conducting SISTEMA evaluations
- Functional Safety experience evaluating PLC based safety systems
- Certifications:
- Certifications such as Certified Safety Professional (CSP), Certified Product Safety Engineer (CPSE), or Certified Compliance Professional (CCP) are preferred.
Additional Requirements:
- Ability to travel domestically and internationally for audits, certifications, or regulatory meetings, as needed.
- Strong organizational skills with the ability to manage multiple projects and deadlines.
EQUAL OPPORTUNITY STATEMENT
It is the policy of Axcelis to provide equal opportunity in all areas of employment for all persons free from discrimination based on race, sex, religion, age, color, national origin, disability status, medical condition (including pregnancy), veteran status, sexual orientation, marital status, or any other characteristic protected by federal, state or local law. Axcelis will provide reasonable accommodation necessary to enable a disabled candidate or employee to perform the essential functions of the position, unless the accommodation would create an undue hardship for the Company.