דרושים Principal Facilities Engineer - Aseptic Manufacturing ב-Boston Scientific ב-ארהב

About the Role:

The Opal HDx Mapping System centers around a real-time virtual world of the human heart. As a physician probes the heart with a catheter, the system generates an accurate anatomical model of the chamber. High-performance rendering and algorithmic techniques are vital to creating a stunning view and providing the physician with instant feedback.

Our technology includes C++ (C++11 or newer), Linux, MATLAB

Key Responsibilities:

The Senior Software Engineer will have a key role in the development of algorithms for cutting edge medical applications in the field of Cardiac arrhythmia diagnosis and treatment. The responsibilities will include:

• Provide technical leadership to the team in software architecture and best in class software development methodologies and practices.
• Architect, design, develop and release innovative high performance medical device software.
• Solve difficult problems, improve state of the art, and achieve engineering excellence.

• Collaborate across disciplines effectively (HW, Systems, Test, Quality, Regulatory) to focus and maximize end-to-end solution value and quality

• Participates in preclinical system experiments in the lab, with physicians, and 3rd parties

Requirements:

• BS/MS in Computer Science or equivalent experience, with a strong software development background.

• 5+ years relevant Experience
• C++ development and debugging Experience

• Algorithm development experience using MATLAB

• Experience with Object Oriented programming principles

• Excellent analytical and problem-solving skills
• Ability to contribute to multiple projects in parallel
• Implements, tests, troubleshoots, and debugs source code for complex software applications
• Follow the full design life cycle process including driving efforts in requirements specification, design activities, planning, code reviews and creating corresponding artifacts.
• Participate in the development of technical documentation, including design specifications, test plans, and user manuals.
• Promote a collaborative environment and pragmatic engineering decision-making.
• Identify and implement continuous improvements to work processes and tools.
• Support field clinical staff on use of medical software and troubleshooting of issues.

Preferred Qualifications:

• Experience with developing on the Linux platform

• Experience with scrum framework

• Good written and verbal communication skills. General report writing/documentation experience
• Experience with medical device standards including IEC 62304, 60601, ISO 14971, 13485

• Experience with software configuration management tools for source code control (Git), issue tracking (Jira), requirements management (JAMA)
• A good learner who can master complex software and quickly adapt to new tools and technologies.
• Experience mentoring lower-level engineers

• Hybrid Work Mode
• Travel 0-10%

Maximum Salary: $ 164500

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.

Spencer Gregory Hale

Your responsibilities include:

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
• Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing-related.
• Supports Supplier Change Impact Assessments for process changes at suppliers.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.

New Product Development:

• Execute SFMD Plan deliverables for onboarding of products into BSC’s Quality System.
• Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

Quality System Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Identifies and advises management on potential improvements to quality systems and processes in the company.
• Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you:
Minimal Qualifications:

• BS degree in engineering or technical field with minimum of 2 years of relevant experience in quality engineering.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, SCAR.
• Organized and self-driven.
• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%.

Preferred Qualifications:

• 3+ years of medical device engineering experience preferred.
• Medical Device Industry experience
• Problem Solving and Project Management experience
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.

Maximum Salary: $ 138300

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.

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.

About the role:

With general supervision, you will work on the weekend shift as part of a technician team in the Access and Delivery Solutions Assembly (ADSA) business unit. ADSA weekend shift runs Friday-Sunday from 6:00am to 6:00pm.

ADSA is a subassembly producer for the greater BSC network, providing multi-component shafts and tubes for assembly into completed products at downstream partners. Equipment used on the ADSA floor includes both off-the-shelf and custom-built equipment such as cutters, lasers, traversing ovens, test equipment, and other ancillary equipment.

Your responsibilities will include:

• Troubleshoot and solve equipment and process problems using basic understanding
• Maintenance activities for PLC controlled manufacturing equipment
• Perform standard/common preventative maintenance and calibration tasks on equipment
• Document common/repeat issues for resolution by the ME team
• Demonstrate familiarity with tooling and fixtures
• Execute simple tooling and equipment qualifications with guidance
• Assist the ME Team in executing Value Improvement Projects (VIP) to improve/revise existing processes for cost savings
• Provide technical support or direction to operators and medical device specialists with assistance
• Support shutdowns (which may include staying late to make sure equipment is safely de-energized)

Required qualifications:

• 2 years with high school diploma/degree/equivalent

Preferred qualifications:

• Strong hands-on mechanical skills
• Communicates well in both written and verbal forms
• Works well both individually and in a team
• Self-motivated to seek out opportunities to improve business performance
• Experience in a manufacturing environment preferred
• Medical device industry experience preferred
• Electro-mechanical trouble shooting experience preferred
• Control system experience such as interfacing with PLC
• Hands-on experience with measurement systems, such as: calipers, micrometers, tool scopes, etc.
• Experience with mechanical print reading
• Computer skills in MS Word, Excel, and Outlook
• Basic understanding of Lean principles
• Heat transfer equipment troubleshooting experience
• Laser weld equipment troubleshooting experience
• Ability to lift 50 lbs. (occasionally)

Maximum Salary: $ 71552

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.

Your responsibilities will include:

• Identify and fix problems that arise during the extrusion process in a quick and effective manner to minimize downtime
• Perform routine maintenances and document the details in the machine maintenance system in compliance with the Quality System
• Monitor processes and perform adjustments to ensure product quality
• Evaluates and orders necessary equipment, tools and fixtures.
• Revise existing documents, processes, and/or methods to correct or improve processes/product
• Ability to handle the physical demands of the job, including moving equipment, standing for long periods, and handling materials
• Work with vendors/suppliers to procure and install tooling, fixtures, and/or equipment
• Participate in the redesign and/or development of equipment with the Process Development team to enable the integration of new products
• Contribute toward Core Tech Polymers Continuous Improvement initiatives to enhance performance, reduce downtime, improve overall manufacturing efficiency, and other Value Improvement Projects (VIP)

Required qualifications:

• 3 years with High School Diploma and/or equivalent experience, training, or apprenticeships

Maximum Salary: $ 91416

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.

Your responsibilities will include:

• Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
• Works independently to plan and schedule own activities necessary to meet timelines.
• Designs and coordinates standard engineering tests and experiments.
• Designs, procures, and fabricates tooling and fixtures.
• Performs troubleshooting on new products/process problems as related to design, material, or process.
• Summarizes, analyzes, and draws conclusions from test results.
• Prepares standard reports/documentation to communicate results to technical community.
• Responsible for engineering documentation.
• Invents/creates concepts and designs for new products/processes and submits idea disclosures.
• Trains and provides work direction to technicians.
• Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
• Demonstrates PDP/TPD system knowledge through delivery of high-quality deliverables.

Required qualifications:

• BS or above in Mechanical Engineering, Biomedical Engineering, or related field.
• 2+ years of engineering experience with a Bachelor’s degree, 1+ years with a Master’s degree

• Passion for understanding and solving problems with an ability to quickly learn and understand complex subject matter

• Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills.
• A driven individual who takes accountability to plan, schedule and execute activities necessary to meet project timelines to schedule

Preferred qualifications:

• Experience in the medical device industry with a strong understanding of design controls.
• Demonstrated strong cross-functional collaboration, influence without authority, and project/task management enabling highly effective teams

Maximum Salary: $ 132000

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.

Our Purpose:

You’ll contribute to the design and advancement of medical device and equipment systems across multiple product lines, using a mix of emerging and proven technologies to improve patient outcomes and clinician experiences. This role offers exposure to global collaboration, cross-functional teamwork, and long-term career growth.

In addition to engineering contributions, you’ll provide industry-leading technical support to Boston Scientific field personnel, clinicians, and internal stakeholders—ensuring timely, accurate, and actionable information about current and legacy R&D products.

Your responsabilities will include:

• Develop technical knowledge of Competetive Products and Systems to enable product solutions
• Maintain up-to-date general industry knowledge
• Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to inmpove workflow and work processes
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
• Must have good communication and interpersonal skills.
• Provide Technical support, as required, to TDP/PDP Teams
• Must be a Self Starter, manage own time and prioritize based on business priorities.

Required Qualifications:

• Former Boston Scientific Intern or Co-op
• Pursuing a Bachelor’s Degree in Electrical Engineering

• Experience using Python in a work setting
• Experience using Verilog in a work setting

Preferred Qualifications:

• Experience with medical device industry standards
• Strong communications and time management abilitites
• Travel on average 10% to BSC divisions and suppliers world-wide

Quality System Requirements

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Maximum Salary: $ 110500

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.

Maximum Salary: $ 71552

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.