Tactical Purchasing Team Leader jobs at Boston Scientific in Israel

Your Responsibilities will Include:

• Utilize research and experience to develop new product and processes to increase performance.
• Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives.
• Collaborate with external suppliers for component and process design and identify outsourcing opportunities.
• Provide technical leadership and maintain the engineering staff’s knowledge of technology and engineering areas associated with instrument and mechanism design and manufacturing processes.
• Understand the technology and key product features that ensure clinical and commercial success
• Manage research and development activities from Concept Phase through Commercialization
• Make data driven decisions using appropriate analytical methodologies
• Prepare for and conduct various design reviews in accordance with product development
• Demonstrate deep insight regarding design intent and uses insight to drive product requirements and specifications. Develop processes necessary to fabricate devices. Develop and implement test methods for assessing the quality of in-process and finished products.
• Develop, execute, and analyze design verification and validation studies, culminating in a design history file.
• Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.)
• Provide technical leadership along with technical subject matter expertise to product development team.
• Conduct preclinical build operations as necessary.
• Initiate, define, perform and execute verification and validation activities.
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities.
• Perform risk analysis activities and develop product testing plans and protocols; set up and run product testing and protocols in accordance with project plans
• Research and recommend vendor and material choices for product
• Identify hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis.
• Comply and analyze data, identify causes, draw conclusions, generate reports.
• Create and manage a schedule of technical deliverables in coordination with a project manager.
• Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders.

Required Qualifications:

• MS/PhD degree in Materials Science, or Mechanical Engineering w/emphasis on materials engineering preferred. BS in one of those fields will be considered but will be weighed heavily on work experience.
• Minimum of 7 years of experience in medical device engineering.
• Polymer knowledge along with extrusion, injection molding experience and metallurgy.
• Knowledge of and exposure to product testing and data collection
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
• Working knowledge of mechanical design principles and FDA class 3 regulated medical device design controls.
• Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred. This includes experience with medical device materials 7+ years product development, preferably in medical device industry.
• Proficient in CAD software, preferably SolidWorks.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
• Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD)
• Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project teams.
• Knowledge, Skills, and Abilities:
• Excellent hands-on mechanical prototyping, verification, and failure analysis skills.
• Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA).
• Strong leadership skills and mentoring capabilities
• Strong quantitative analysis and problem-solving skills and methodologies
• Strong interpersonal and communication skills (oral/presentation and written)
• A flexible team player, focusing on shared goals with a positive results‐oriented attitude.

Preferred Qualifications:

• Proficient in Risk Management according to ISO 14971.
• Knowledge of ASME Y14.5 GD&T.

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

As the EMC & Safety Team Leader, you will ensure compliance with medical standards and address compliance obstacles early. You will coordinate with external notify bodies and internal teams to align programs, enhance efficiency, and plan the overall site compliance to relevant standards. You will verify that medical devices are developed and manufactured according to regulatory standards and act as the subject matter expert for collaborations with SII and external labs.

Main Duties:

• Responsible for EMC and Safety activities at the site.

• Responsible for Compliance to state of the art standards
• Manage Sustain and NPD safety and EMC engineers
• Manage subject matter experts for each standard
• Maintain PSL (Product Standard list ) evidence in Atlas
• Maintain compliance for other standards (RoHS, Usability, Environmental etc.)
• Identify noncompliance, lead the technical aspects of EMC /Safety risk assessment and close gaps
• Plan and Maintain compliance with standards updates
• Support Audits (NPD & Sustain) focusing EMC/Safety topics
• Providing status reports concerning all Safety & EMC activities.
• Collaborating with R&D / Engineering in Design review of the device to achieve robust level of safety & EMC
• Collaborating with V&V Team during sustain phase of the product.
• Attending meetings, writing Protocols & Reports and communicating presentations to managers and clients.
• Attending audits and meetings with subcontractors in Israel and abroad
• Keep updating and learning new regulations.

Required Qualifications:

• B.Sc. in Electrical Engineering - mandatory
• 7+ years of experience in multi-disciplinary Medical Device company - mandatory
• Proven work with EMC & Safety of Medical regulatory standards and certification requirements (e.g. UL, CSA, IEC, particular IEC60601-1, IEC60601-1-2 ,IEC60601-22)
• Ability to read and interpret regulatory standards and to consolidate requirements for technical audiences.
• Experience with laboratory instrumentation, Hands-On (analog/digital meters, oscilloscopes, data acquisition systems, etc.)
• Electrical Troubleshooting problem-solving skills & design for EMI & Safety.
• Ability to develop and document departmental work procedures.
• Systemic & Process point-of-view Skills.
• Strong attention to detailed and high accuracy capabilities.
• Excellent communication in Hebrew and English (verbally and written).
• Good organizational and Leading skills.
• Highly Methodical and organized
• Basic Microsoft Office proficiency
• Driving License

The role of Electrical Team Lead in our NPD R&D team involves steering projects in the electrical and electronic subsystems of our medical laser console portfolio. You'll be at the forefront of developing our new systems.

Key Responsibilities:

• Lead NPD R&D EE team from both professional and organizational aspects.
• Take a part in defining the future of system architecture.
• Actively participate in project teams, contributing to specifications, design enhancements, and defining timelines for electrical design.
• Develop electrical designs using BSC’s standard development tools and procedures.
• Ensure timely project completion, monitoring schedules, and adapting to changes.
• Generate standard reports to communicate project status and results.
• Collaborate with Sustain R&D Electrical engineering team.
• Be involved in EMC/Safety, Design, and testing.

Requirements:

• B.Sc. in Electrical Engineering.
• Minimum of 10 years of experience in Electronics Engineering, including at least 3 years in a leadership role"
• Minimum 5 years of experience in Medical Devices - big advanatage/Defense/Aviation/Automotive industries/
• Advantageous to have experience in 60601-1 Standards, Design, and testing.
• Hands-on experience in both Power /Analog and Digital Hardware.
• Proven team leadership skills and experience.
• Strong communication skills in English.