Data Engineer - Framework Team jobs in Israel

Key Responsibilities:

• Identifying and resolving the root causes of complex technical issues with production equipment.
• Performing troubleshooting on the equipment on the production lines.
• Perform hands-on repair of complex technical issues with equipment.
• Documentation of performed work and updating Preventive maintenance procedures as required.
• Responsible for developing new Jigs, Fixtures, Testing, and Manufacturing equipment.
• Creates mechanical designs and detail drawings utilizing CAD modeling software per department standards, development tools, and procedures.
• Designs pneumatic and hydraulic systems and specifies basic pneumatic and hydraulic components.
• Defining basic electrical components and automated control requirements.
• Ensure relevant documentation is prepared in line with all Quality and Regulatory guidelines and promotes full compliance with all GMP & E&AS
• Sustain an environment of continuous improvement.
• Develop and implement the appropriate maintenance procedures and protocols to ensure processes always remain in control.
• Manage the planning and execution of equipment validations and qualifications

Requirements:

• Bsc in Mecahnical Engineering
• 3-5 years of experience as a Mechanical or Equipment Engineer.
• Experience working on production lines.
• Hands on experience in mechanical design using SolidWorks.
• High proficiency in English (writing and speaking)
• Experience working with PDM software - An Advantage.
• Experience working in the medical industry - An advantage.
• Control systems experience – an advantage.
• Electrical design knowledge – an advantage.
• Providing technical leadership on maintenance and equipment issues.

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.