Packaging Engineer Iii jobs at Boston Scientific 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.

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:

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

You'll support our growing Medical Electrical Equipment portfolio, ensuring top-quality products and exceptional customer experiences.

Responsibilities:

• Lead efforts to identify root causes of service process nonconformances and implement corrective actions
• Develop and implement service quality plans, documents, and systems
• Monitor product performance and devise methods to reduce nonconformances
• Collect and analyze field product performance data to enhance service processes
• Create quality tools and training materials
• Evaluate the adequacy and compliance of systems, operations, and practices
• Actively participates and partners in Global Installation and Servicing community of practice to identify opportunities and drive improvements
• Support and lead improvement projects to sustain the Quality Strategy
• Supports internal and external regulatory audits

Required qualifications:

• BSc in Industrial/Biomedical/Mechanical/Electrical Engineering, or related degree
• Minimum of 5 years of experience in a Quality role within the Medical Device industry
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements
• Solid technical writing skills
• Strong communication and presentation skills
• Travel <10%, if required
• High proficiency in spoken and written English.

Main Duties:

• Member of integrated product team (IPT)- responsible for supporting activities required to ensure quality of the design though compliance with design controls.
• Lead proactive design assurance activities facilitating the development and release of high-quality products.
• Review and approve product design document- in accordance with design controls standards and company’s policies. This includes but is not limited to design verification and design validation activities.
• Parenting with R&D- ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
• Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
• Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
• Partnering with R&D, RA, Clinic affairs and BU, ensure that pre-release elements of risk management activities are properly conducted and included within the applicable risk management file.

Required Qualifications:

• Bachelors’ degree in Life Science, Engineering field or second degree in fields of quality and statistics
• Proven experience in quality systems (4- 5 years) and in medical device field (minimum 3 years).
• Experience working in an FDA and ISO 13485 regulated environment.
• Project management skills, strong communication, problem solving, and analytical skills are required.
• Leadership skills without direct authority responsibility
• Strong English capabilities.