Safety & Regulatory Engineer

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

General Job Description

The Safety & Regulatory (S&R) Engineer leads the regulatory compliance (Safety, EMC, particular and collateral standards) and ATM (Authorization to Mark) for all laser franchise systems.

The S&R Eng. works closely with external testing bodies and regulatory agencies, as well as with our internal R&D, RA and QA teams to ensure compliance of our NPD and Sustain products with the applicable medical standards, while clearing compliance obstacles as early as possible.

The S&R provides wide view of cross programs alignment to improve commonality, efficiency, and costs.

Main Duties

• Focal point to external labs/ testing bodies and regulatory agencies.
• Plan, quote, communicate and approve reports for external lab test bodies.
• Own the transfer from regulation to engineering derivatives – deployment plan, impact assessment, effort estimations and follow up.
• Support the establishment of the regulatory design inputs.
• R&D representative for regulatory driven changes and approver of ECOs for applicable design changes.
• Escort NPDs from design phase to ensure compliance at early phases and train the R&D personal on standards requirements.
• Perform new standards gap analysis and assess changes applicability to our products.
• Support External audits and production follow-up inspections (CSA/Intertek).
• Advising for critical components incoming inspection and suppliers quality, sending critical components to annual inspection.
• Follow up on reports update from external labs and testing bodies, following design changes.
• R&D representative of Laser franchise in global standards CoP.
  
  

Required Qualifications

• BSc (or practical Eng.) in Electrical Engineering, Electro-optical Engineering, Mechanical Engineering, Bio-medical Engineering, from a leading university. Master degree - advantage.
• At least 3 years of experience in managing compliance of multi-disciplinary products, including HW, Mechanics, Software and Physics.
• Deep understanding and experience with the IEC60601-1 and 60601-2 standards.
• Interpersonal skills and excellent teamwork - the ability to meet technical as well as human challenges.
• Experience and creativity to overcome compliance challenges, be “hands on” when needed.
• Fluent in Hebrew and English
• Good documentation skills
• Experience in Medical devices - advantage.
• Experience in a global company – advantage
• Knowledge of optics / laser - an advantage
  
  

Requisition ID: [[572583]]

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!