Boston Scientific Principal Systems Design Quality Assurance DQA Engineer 

Israel, North District 

206715348

About the role:

and associated accessories

As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; To help patients in need get back to their daily lives. As a Principal Design Quality Assurance (DQA) Engineer, you’ll be at the heart of that mission to develop and support best-in-class products to bring advanced, safe innovations to the clinic. You will also be leading the effort todevelop MEE /

Your responsibilities include:

• Lead product teams within the BSC Quality System to develop new MEE and MES as part of a core group of DQA Engineers supporting the Laser Therapies franchise. Special focus on:
• Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
• Utilize Systems Engineering practices to lead efforts for requirements management/system architecture to align risk mitigations with design inputs, design outputs at different levels (e.g., system / sub-system) for products that are both stand alone, and network connected.
• Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Lead Risk Management activities during all phases of Electrical HW/SW design, using design quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
• Participate and lead inthe creation and maintenance of Risk Management and Usability deliverables.
• Lead and/or support development of NPD Reliability Engineering Program Plans and related reliability program activities.
• May perform other duties as directed.

Minimum Qualifications

• B.Sc in Biomedical, Electrical Engineering or equivalent.
• 7-8 years of Medical device engineering experience, with experience inMedical Electrical Equipment/Systems (MEE / MES).
• Experience with Reliability and Systems Engineering principles
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971 and EN ISO 13485.
• Strong leadership skills.
• Hands on team player.
• Coaches others in analysis and decision making. Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and/or other electrical testing/simulation software.
• Travel approximately 5-10%.

Preferred Qualifications

• Certified Reliability Engineer and/or Systems Engineer
• Experience with Software as a Medical Device (SaMD) and/or systems integration