Job Title: Design Controls and Risk analysis Specialist
Location: Caesarea, Israel
Reports to: Design Control Manager
Job Description: Unique opportunity to work across all Mazor Robotics' product platforms and to optimize and maintain key processes leading to our world-class robotics system. The main focus of this position is Design Control (including risks analysis) for new product development and product maintenance.
Key Responsibilities & Authorities:
- Developing and maintaining standard operating procedures (SOPs).
- Continuously improve the Design Control and Risk Analysis processes for effective execution while staying in compliance, which strengthens our ability to get new products and product changes faster to market.
- Training and educating all users in product development/maintenance processes focusing on design control and Risk Analysis SOPs.
- Staying up to date and having an in-depth understanding of requirements in regulations/standards like 21CFR820.30, ISO13485, ISO14971, IEC62366, IEC62304 and the new EU IVD/MD regulation.
- Ensure product compliance for the assigned projects.
- Compile Design Control documentation and contributing to a high quality of the Design History File (DHF).
- Establishes/Participates in the documentation strategy.
- Support technical activities within the development and commercialization.
- A Technical degree Science/Engineering or Mechanical Engineering or University level engineering education or similar related background.
- Experience is required (minimum of three (3) years), in medical device industry with a strong emphasis on quality assurance, device development from early phase activities up to commercialization, problem solving, along with written and verbal skills.
- Advance knowledge with Medical Device Quality Systems, ISO 13485:2003, CFR21 Part 820, EU Medical Device Directive.
- DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects.
- Background in mechanical engineering in general.
General understanding of Human Factors Engineering and Risk management.
- Good technical knowledge in multi-disciplined systems
Job Specific Skills (Languages, SW, systems, etc.'):
Excellent skills in English language are required (read and write)
Office in high level
ALM (Qpack) – an advantage
PLM (WCL) – an advantage
Other Requirements for the role (% of travel, etc.):
Professional, independence, quick learner and a team player with excellent interpersonal skills.
Good communication and conflict solving skills
Internal: As Design Control and Risk analysis Specialist, you work together with many stakeholders in Product, R&D, RA/QA and Operations departments.