Company Statement:
Give hope. Give health. Make your mark in the fight against cancer.
At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.
Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.
1. SUMMARY:
The Compliance Engineer in our Product Development department is responsible for establishing compliance strategies and plans across products and projects, identifying and tracking relevant standards and regulations, and leading and participating in conformity assessment including execution and facilitation of third-party agency testing. This position will primarily focus on activities for Chinese market registrations.
2. REPORTING TO/DEPARTMENT:
Reports to the Compliance Engineering Group Leader in the Systems Engineering department
3. ESSENTIAL DUTIES AND RESPONSIBILITIES:
61 Develop and implement plans to verify compliance including conformance assessment, internal testing, and facilitation of third-party testing
61 Develop and maintain a strong working knowledge of standards (e.g. GB 9706.1-2020, GB9706.102-2020, GB 9706.201-2020, GB9706.268-2022), including the evaluation of new and emerging standards, and be able to determine relevance and product impact
61 Track progress to compliance objectives through the development cycle, facilitating regular review of progress to objectives, and identifying mitigations to address anticipated compliance issues
61 Develop user and system-level product compliance requirements that are relevant to our products and the associated target markets, and, working with subsystem owners and subject matter experts, allocate those requirements to subsystem and component levels
61 Guide and review development activities to ensure compliant designs, identifying and prioritizing design risks and mitigations to eliminate or reduce those risks as early as possible in the development cycle
61 Provide guidance to organizations including service, manufacturing, and quality to sustain compliance requirements on released product
61 Support functional and project managers in establishing and updating project milestones and schedules to ensure compliance activities are represented
61 Work effectively with other engineers and scientists, internal and external
61 Tasks and priorities are project-driven and may be individual or cross-functional
61 Travel within China will be required for technical visits to support compliance related activities at other Accuray sites; travel to Accuray sites in the USA may also be required
4. CORE COMPETENCIES:
61 Personal Excellence
o Effective in communication, demonstrates professionalism at all times, and has an accurate picture of self
61 Strengthening the Team
o Demonstrates high performance standards and effectively collaborates with the team, demonstrates a sense of ownership over assigned deliverables, and shows a high degree of motivation toward achieving individual and team goals
61 Drive for Results
o Applies financial discipline and a good business sense, supports change, and makes high quality and timely decisions
5. REQUIRED QUALIFICATIONS:
61 Preferred or Desired:
61 Experience with medical device related standards and their application to large capital equipment systems.
61 Experience with third party evaluation.
61 An advanced technical degree or certification(s) related to compliance standards or testing and evaluation.
61 Knowledge of risk assessment and its relationship to product safety standards and compliance.
61 Knowledge of other compliance domains such as software development or cybersecurity.
61 Required:
61 Bachelor’s degree in engineering, math, or science, and at least 3 years of development and/or compliance experience in a highly regulated industry.
61 Suitable work experience in a technically related field may be considered in lieu of formal education.
61 Be fluent in Chinese and English.
61 Familiarity with product safety and performance standards.
61 Familiarity with EMC standards and testing methods.
61 Basic understanding of control systems, equipment power supply and distribution, electronics, electromagnetic compatibility, and computer systems.
61 Hands-on experience with electronic test equipment.
61 Excellent troubleshooting and problem-solving skills.
61 Good verbal and written communication skills.
61 Proficient computer skills, including standard office software.
61 Ability to organize and coordinate technical tasks for other engineers