דרושים Manufacturing Technician Iii - 3rd Shift ב-Boston Scientific ב-ארהב

About this role:

As a Clinical Evaluation Scientist III, you will develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.

Your responsibilities will include:

• Apply analytical and methodical clinical evaluation approaches to develop benefit-risk profiles for Boston Scientific’s interventional cardiology devices.
• Author and maintain clinical documentation including CERs, PMCF reports, and SSCPs in alignment with regulatory standards.
• Collaborate cross-functionally to ensure clinical content supports product approvals, indication expansions, claims, and post-market requirements.
• Interpret and synthesize data from multiple sources to produce high-quality, compliant clinical evaluations.
• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
• Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.
• Collaborate with leadership and cross-functional partners to ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
• Aid in the development and execution of strategies for regulatory responses for regulatory submissions

Required qualifications:

• Minimum Bachelor’s degree and 3 years of medical writing experience, preferably in medical device industry
• Analytical skills, including strong familiarity with medical literature
• Proven experience writing clinical evaluation reports
• Proven experience applying principles of EU MDR

Preferred qualifications:

• Preferred medical device industry experience or knowledge of interventional cardiology and related disease states
• Proven and demonstrated ability to understand engineering documentation, including risk documentation
• Proven experience with regulatory body communications

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.

Your responsibilities include:

• In partnership with production, quality, and engineering ensure sustainment and effectiveness of training processes in Cardiac Diagnostics manufacturing
• Rapidly respond to, investigate, and resolve line impacting training issues/errors
• Support Operations in the development of new training plans
• Coach Production team members on applications of Training and Development tools and policies
• Partner with Production Supervisors to develop and certify production trainers
• Provide audit support, guidance, and direction on training policy and adherence
• Participate in developing the strategy of Boston Scientific Operations training practices and policies
• Participate in cross-functional projects to continuously improve the business and training programs
• Develop and deliver training based on business needs (i.e. PowerPoint, partner with internal customers to create course material as needed)

Required requirements:

• High School diploma or equivalent certification
• Minimum of 5 years manufacturing experience
• Basic computer skills (Microsoft office-word, PowerPoint, Excel)
• Strong communication, interpersonal, and organizational skills
• Passion for training, coaching, and mentoring others
• Ability and willingness to adapt to continuous change while maintaining a positive outlook

Preferred qualifications:

• Minimum one year experience as a trainer in a production environment
• Ability to think and act proactively
• Self-Motivated
• Positive, ‘can-do’ approach

Maximum Salary: $ 80808

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.

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.

As a Field Service Technician II at Boston Scientific, you will be responsible for delivering exceptional customer support and technical service for our advanced laser and light-based medical equipment. You will perform on-site installation, routine maintenance, troubleshooting, and repair while acting as a key liaison between Boston Scientific and our customers. This is a critical role that ensures our innovative technologies continue to make a positive impact on patient care. This position is based in Tennessee. You will operate within a designated territory, with frequent travel to surrounding areas. While you’ll work independently, you will also collaborate closely with senior team members for support and mentorship.

Your responsibilities will include:

• Provide on-site installation, maintenance, and repair services for Boston Scientific’s laser and light-based medical equipment.

• Educate customers on system operation, maintenance procedures, and troubleshooting.

• Act as the primary company liaison with customers for technical matters.

• Resolve a wide range of technical issues using defined methods and troubleshooting techniques.

• Perform routine and emergency maintenance, modifications, recalibrations, and repairs of capital equipment and accessories.

• Document all service activities accurately and in a timely manner using company-specific reporting tools.

• Ensure high levels of customer satisfaction with equipment and services provided.

• Adhere to standard operating procedures and regulatory requirements to maintain quality and compliance.

Required qualifications:

• Minimum of 1 year of experience with an Associate’s degree in Electronics, Biomedical Engineering, or related field (equivalent education and experience will be considered).

• Strong knowledge of electronic systems, including analog and digital circuitry.

• Proficient in troubleshooting and repairing complex medical equipment.

• Ability to travel approximately 75% of the time within the designated region.

• Excellent communication skills, with the ability to interact effectively with customers and diverse teams.

• Strong organizational skills and ability to manage multiple service calls and administrative tasks.

• Must have a service vehicle that meets company insurance requirements.

• Clean driving record and ability to lift up to 75 lbs.

Preferred qualifications:

• Bachelor’s degree in Electronics, Biomedical Engineering, or related field, with at least 5 years' experience in electronic system troubleshooting.

• Experience in technical field service, particularly in the medical or biomedical field.

• Experience with lasers and optics.

• Coursework or certification in Laser Technology or Optics.

• Prior experience in hospitals and/or ambulatory surgery centers.

• Proficiency with business software tools, including Microsoft Office Suite.

• Ability to work independently and manage multiple assignments with minimal supervision.

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.

Work Mode

This role follows an onsite work model, requiring employees to be in our Axonics office five days per week. The address of the office is 15515 Sand Canyon Ave, Irvine, CA 92618.

Your responsibilities will include:

• Designs and develops software applications that meet customer needs.
• Writes high-quality, clean, and flawless code to complete functional applications on schedule.
• Implements, tests, troubleshoots, and debugs source code for software applications.
• Understands customer requirements and how they translate to application features.
• Collaborates with engineering and marketing teams.
• Evaluates existing applications to update and add new features.
• Ensure mobile application compliance to appropriate regulations.
• Assist in design and development of cloud backend as necessary

Required qualifications:

• Bachelor’s degree or higher in Software Engineering, Computer Engineering, or Computer Science.
• 4+ years of experience developing cross platform applications for iOS and Android
• Excellent analytical and problem-solving skills. Able to think creatively to find solutions.
• Experience working with domestic and international regulatory agencies.
• Sound knowledge of software engineering principles and practices.
• Knowledge of programming languages such as Swift, Java, Dart, or Objective-C and mobile operating systems and platforms such as iOS and Android.
• Knowledge of API design
• Knowledge and use of OOP design principles
• Successfully demonstrated collaboration with cross-functional teams.
• Knowledge of UI/UX design principles is a plus.

Preferred qualifications:

• Experience in developing mobile applications in an FDA regulated environment or other regulated industry.
• Experience in interfacing BLE enabled medical devices to mobile applications.
• Detailed knowledge of BLE stacks and BLE API on mobile platforms
• Knowlege of ISO 13485 and FDA QSR
• Knowledge of cybersecurity considerations in an FDA regulated framework
• Excellent written, verbal, and visual communicator.
• Detail oriented and excellent time-management skills.

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.

About the role:

The Quality Technician I in this role will provide direct Quality support for the medical device manufacturing in the Nitinol Shape Memory (NSM) Business Unit on 3rd Shift. This position is expected to provide day-to-day onsite floor support for the production team to address Quality problems and questions. This role requires cross-functional collaboration across Production, Manufacturing and Quality to develop, apply, monitor, improve and communicate Quality events. This role requires the individual to drive continuous improvement within product quality and compliance as well as the ownership and reporting of nonconformance. This position requires critical and creative thinking to perform investigations to resolve problems that arise on the production floor.

Your responsibilities will include:

• Provide Quality floor support to the Production Team.
• Perform project and product testing.
• Lead and assist Engineers in Failure Investigations associated with Nonconformance and CAPA Activities.
• Document and own nonconforming events associated with material, designs and/or systems which may include: containment of impacted material(s), failure investigation, dispositioning of material, risk assessment evaluation and corrections.
• Participate in continuous improvement projects.
• Assist with quality issues and quality metrics related activities.
• Assist with product failure analysis.
• Perform testing, gather data, and analyze results of product testing and process monitoring.
• May assist with audit-related activities.
• Assist with CAPA activities.
• Assist in creating, validating, and maintaining data files and forms.
• Use documentation systems to research information and generate Change Notifications and/or Process Change Analysis Requests.
• Assist in developing and qualifying test methods, data sheets, test fixtures, and testing equipment.
• Review device history records (DHR) and acceptance records to ensure all activities in the Device Master Record (DMR) have been performed and approved.
• Update and maintain databases and spreadsheets used to track, monitor, and report department activities.
• Use the inventory and traceability management systems to transact and research material.
• Communicate with a wide variety of BSC personnel in and outside of the plant.

Required qualifications:

• High school diploma/degree/equivalent work experience

Preferred qualications:

• AA degree or Higher
• Experience in the medical device field in a quality role
• Experience in MES, SAP or equivalent MRP system
• Lean manufacturing experience
• Workstation error proofing experience
• Proficient in Microsoft office (Excel, Word, PowerPoint, OneNote, etc.)
• Strong written and verbal communication skills
• Must work well in a team environment
• Technical background with a passion for continuous improvement
• Ensure compliance with company policies and procedures
• Self-motivated individual with a drive to succeed

Maximum Salary: $ 63856

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.