Principal Upstream Product Manager jobs at Boston Scientific in Israel

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

Your Responsibilities Include:

• Lead cross-functional project teams to the successful completion of project goals. Work includes ensuring scope of work, costs, schedules, and risks are properly planned, resourced, and managed.

• Build team ownership and commitment to projects and assign clear authority and accountability.

• Lead strong and agile project risk management in a dynamic and innovative R&D division.

• Support the team with all program activities, overview technical challenges, thoroughly analyze problems, identify potential solutions and their ultimate impact on the program and business.

• Lead program phases and gates, lead transition to new quality system.

• Prioritize, delegate, and manage activities among team members, as appropriate, to drive execution of projects deliverables.

• Manage contracts with vendors and suppliers by assigning tasks, communicating expected deliverables and oversee projects procurement management

• Monitor progress, provide program updates on a consistent basis and report out and up program progress and status.

• Drives results by acting with speed and agility. Eliminate blockers, identify program risks and areas that need improvement and act to advance them with the relevant stakeholders

• Develop content that is in compliant with EU MDR, US FDA and global regulatory requirements, and all relevant BSC QS requirements.

• Create and manage detailed comprehensive plans of large multidisciplinary product development

Requirements:

• BSc/MSc in Mechanical/Electrical/Software/Biomedical engineering or equivalent

• Over 7 years of working experience as a project/program manager

• Over 7 years of demonstrated experience in R&D, new product development, and multidisciplinary products

• Over 5 years leading cross-functional global teams through all project phases, Experience in the medical device industry is highly preferred

• Strong Strategic thinking, Excellent analytical and problem-solving skills, Creative and agile mindset.

• Team player with experience working in collaborative environment and promoting a teamwork mentality in a matrix organization

• Excellent communication and interpersonal skills

• Fluent English

• Self-starter, Productive, highly motivated with “can do” approach

• In- depth knowledge of project management tools, methodologies and best practices

Key Responsibilities:

• Responsible for Manufacturing Engineering and Process Development
• Works with Value Stream and Quality Engineering Manager to deliver business objectives – lean manufacturing metrics, VIP, cycle time, scrap as %VOP etc.
• Responsible for developing a world class-manufacturing group that is proficient in problem solving manufacturing issues using Six-Sigma tools.
• Drives IBP (Integrated Business Plan) contract deliverables by providing input on process technology selection.
• Develops and executes departmental budgets and capital spending.
• Leads or represents function in periodic business metric reviews.
• Initiates cross-functional partnerships to identify and resolve production/engineering issues.
• Prioritizes and drives execution of multiple complex department projects.
• Sponsors and supports Operations Value Improvement Process VIP) or Strategic Activity Review (STAR) projects.
• Responsible for the departmental basics including budgeting, hiring, day-to-day Management, project resourcing, etc.
• Ensure employees are trained to do their work and their training is documented.

Requirements:

• BSC in Mechanical Engineering/Aerospace Engineering/Industrial Engineering/Electronics Engineering - mandatory
• 10+ years of experience in Manufacturing Engineering- mandatory
• At least 2 years of experience managing a team of 3-5 employees- mandatory
• Experience in process industries - Medical Devices/Aerospace/Defense/Automotive industries- mandatory
• Experience with budget management, people management, and task control
• Experience in building a new team, defining vision, roles, and responsibilities
• Experience with employee lifecycle in a company
• Experience in creating work mechanisms and communication with parallel groups, managers, and colleagues
• Ability to create and deliver presentations
• Strong meeting management skills
• Fluent English (high proficiency level)- mandatory