R&d Tech Iii - 1st Shift jobs at Boston Scientific

Technician II, Mfg)

3rd shift

• Responsible for performing functions associated with all manufacturing operations, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, subassemblies, and final assemblies. Determines and may assist in developing methods and procedures to control or modify the manufacturing process. Works with engineers in conducting experiments.

Responsibilities

• Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.

• Identifies and may support implementation of corrective actions for manufacturing related issues

• Performs basic to intermediate equipment setup and corrective, preventive and calibration maintenance as necessary.

• May support Installation and validation of equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.

• Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May assist in development or revision of documents and procedures

• May Certifies manufacturing associates in the production processes of non-critical processes.

• Evaluates and orders necessary equipment, tools and fixtures.

• Evaluates and performs basic tool qualifications to support production activities.

• May lead / Support investigation of out of tolerance event on the production floor

Management Requirements

• Associate Technical Degree (example: instrumentation, electronics) and 3+ years of related work experience or an equivalent combination of education and work experience. Basic knowledge in PLC, vision systems, sensors, pneumatics and mechanical systems preferred. Experience with schematics reading & interpretation. Knowledge in computer and network desirable. Able to work different shift, over time & weekend as needed.

Maximum Salary: $ 55500

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 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.

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.

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.