Design Controls and Risk Analysis Specialist

Job Title: Design Controls and Risk analysis Specialist

Location: Caesarea, Israel

Reports to: Design Control Manager

Department: V&V

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.

Education :

  • 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)

  • Software:

  • 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


Working Relationships:

Internal: As Design Control and Risk analysis Specialist, you work together with many stakeholders in Product, R&D, RA/QA and Operations departments.


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