דרושים Principal Field Training Lead Ep Southeast Us ב-Boston Scientific

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

Software Lead

As a Software Lead, you'll be responsible for overseeing the technical direction of software development projects, managing development teams, and ensuring deliverables meet quality standards and business requirements.

Main Duties:

• Lead and mentor a team of software engineers, providing technical guidance
• Review code, conduct design reviews, and implement best practices for development
• Resolve complex technical challenges
• Communicate project status and technical considerations to both technical and non-technical stakeholders
• Responsible to design, develop and implement software applications running under Windows in multidisciplinary systems
• Responsibility for products software engineering process while maintaining the required standards (Medical device)
• Analyzing and enhancing efficiency, stability and scalability of software resources

Requirements:

• BSC in Computer Science or related technical field
• 7+ years industry experience
• Proven experience in leading software projects or small teams
• Expert level developing in MS Visual Studio C# using WPF and .NET framework.
• Deep understanding of the SW development t lifecycle
• Experience with C++/C# interoperability (C++ CLI or controlling P/Invoke)
• Experience with design patterns, and GUI design patterns)MVVM/MVC(
• Strong understanding of multithreading and object-oriented programming
• Ability to document requirements and specifications throughout the software development life cycle
• Strong familiarity with Agile methodologies
• Experience working in multidisciplinary environment

Key Responsibilities:

• Coordinate and present information for CAPA and NCEP meetings.
• Support corrective and preventive action processes as a CAPA Mentor.
• Collaborate with project teams to create timelines, identify root causes, and develop solutions.
• Partner with CAPA owners to complete phases promptly.
• Analyze data to ensure CAPA and NCEP metrics are met.
• Monitor CAPA implementation and identify site improvement opportunities.
• Engage in preventive activities and represent the site in Boston Scientific Communities of Practice.
• Build relationships with other functional areas and departments.
• Gather data with cross-functional experts to support corporate and site objectives.
• Promote a culture of continuous improvement and compliance within the Quality group.
• Develop strong relationships with site and divisional management.
• Champion continuous improvement activities.
• Support Quality System processes like audits, management review, and document control.

Requirements:

• Bachelor's degree, preferably in Engineering.
• At least 5 years of experience as a CAPA/QMS/Operations Quality Engineer (mandatory).
• Experience in the Medical Devices/Pharmaceutical industry (mandatory).
• Proven written and verbal communication skills for a wide variety of internal and external stakeholders.
• Proficient in English, both verbal and written.
• Proficient in the MS Office suite (Word, Excel, PowerPoint).