דרושים Senior R&d Engineer - Electrophysiology ב-Boston Scientific

Key Responsibilities:

• Designs, develops, maintain, debugs, modifies, tests software of highly regulated medical device
• Documents software development and test development by writing documents, reports, memos, change requests
• Tracks software development effort by creating and maintaining records in the tracking management tool
• Solves engineering problems by analyzing the situation and recommending corrective or alternative actions

Requirements:

• Bachelor's degree in Computer science / Electronics Engineering or equivalent
• 5+ years' experience in Real-Time Embedded SW development in complex multidisciplinary systems
• Demonstrated proficiency in C and C++ programming languages
• Experience with multi-threaded and multi-processor/multi-core systems
• Experience in HW - SW integration and debugging
• Experience with Real-Time operating systems
• Familiarity with writing SW documentation (SRS, SDD and STD)
• Proven problem-solving skills and experience with working independently and collaboratively
• Effective communication and interpersonal skills

Big advantage:

• Experience with medical device software development life cycle
• Experience designing software products in a regulated industry
• Experience with TI C28x DSP’s
• Experience with ARM Cortex M3
• Experience TI-RTOS
• Familiarity in UART, SPI, CAN interfaces
• Familiarity with Jira and Git
• Familiarity with electronic measurement equipment (oscilloscope, multimeter)

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.

To Equipment Engineer will be responsible to engineer and implement highly capable & effective manufacturing equipment to meet business goals and objectives.

Key Responsibilities:

• Responsible for developing testing and manufacturing equipment.
• Create mechanical designs and drawings using Solidworks according to department standards and company procedures.
• Ensure relevant documentation is prepared in line with all Quality and Regulatory guidelines and promotes full compliance with all GMP & E&AS
• Identifying and solving the root cause of complex technical issues with production equipment.
• Writing and execution of equipment qualifications, protocols, and reports.
• Implementation of equipment into the production lines.

Requirements:

• At least 3 years of experience as a Mechanical Engineer.

• Experience working with production lines.

• Experience in mechanical design using SolidWorks.
• High proficiency in English (writing and speaking).
• Experience in writing technical documentation.
• Experience working in the medical industry - An advantage.

• Experience working with PDM software - An Advantage.

• Pneumatic, high-pressure, or Electrical design knowledge – An advantage.
• Working with complex multidisciplinary equipment – An advantage.

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!

About the role:

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 to develop 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 in the 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

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

Your Responsibilities Include:

• Lead cross-functional project teams to the successful completion of project goals. Work includes ensuring the scope of work, schedules, costs, and risks are properly planned, resourced, and managed.
• Lead strong and agile project risk management in a dynamic and innovative R&D division.
• Support the team with all project activities, oversee risks and technical challenges, and evaluate potential solutions and their ultimate impact on the project and business.
• Creating and managing detailed plans of multidisciplinary product development for the R&D and its interfaces.
• Prioritize and manage activities among team members and project interfaces to drive successful execution of the project with a focus on R&D deliverables.
• Monitor progress, create, and provide project status and updates on a consistent basis.
• Drives results by acting with speed and agility. Eliminate blockers and act to advance areas that need improvement with the relevant stakeholders.
• Develop content that is compliant with EU MDR, US FDA global regulatory requirements, and all relevant Boston Scientific QS requirements.
• Lead project phases and gates preparation, drive transition to a new quality system.
• Manage contracts with vendors and suppliers by assigning tasks, communicating expected deliverables, and overseeing project procurement management.

• BSc/MSc in Mechanical/Electrical/Software/Biomedical Engineering or equivalent
• Over 3 years of demonstrated experience as a Project/Program Manager
• Over 5 years of demonstrated experience in R&D/new product development and multidisciplinary products (HW, SW, Mechanics, Electro-Optics)
• Leading cross-functional global teams through all project phases (including transfer to production)- preferred
• Experience in the medical device industry is highly preferred
• Excellent communication and interpersonal skills
• Strong Strategic thinking, Excellent analytical and problem-solving skills, Creative and agile mindset
• Self-starter, proactive, dynamic, highly motivated with a “can do” approach
• Fluent English
• In-depth knowledge of project management tools, methodologies, and best practices