Clinical Evaluation Scientist Iii jobs at Boston Scientific

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.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug 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.

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.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities will include:

• Working with global suppliers to understand manufacturing processes and requirements to ensure the quality and reliability of components can be repeated and reproduced
• Partnering with suppliers and category teams to investigate and resolve supplied material issues and supply constraints
• Leading and collaborating with cross-functional teams to qualify and improve supplier processes; plan, schedule, and coordinate detailed phases of engineering work to meet project deliverables
• Working with divisional project leads to support supplier engineering action items and identify solutions for resource allocation, changes in project requirements and manage escalations
• Troubleshooting processes at supplier facilities to drive quality, reliability, and supply chain improvements
• Leading acquisition and sustaining projects including qualification, supplier change assessments, and restricted material evaluations
• Executing plans to improve supplier performance, mitigate risks of supplied material, optimize costs, and support VIP to meet supply chain objectives
• Maintaining compliance to the Quality Policy and all other documented quality processes and procedures to support the BSC commitment to patient safety and product quality

Required qualifications:

• Bachelor's degree in any engineering discipline with at least 4 years of engineering experience
• Experience working with suppliers and/or contract manufacturers
• Ability to travel up to 25% globally

Preferred qualifications:

• Bachelor’s degree in mechanical engineering, material science, or chemical engineering.
• Experience working in medical device or similarly regulated industry
• Experience with metals fabrication processes: machining, stamping, extrusion, casting, etc.
• Ability to communicate effectively on all levels with strong technical writing and reporting skills
• Organized and detail-oriented; ability to prioritize and manage multiple projects
• Strong interpersonal skills with ability to develop internal and external relationships
• Results-driven with strong critical thinking and analytical skills
• Good understanding of statistical methods, problem-solving techniques and six sigma methodologies

Maximum Salary: $ 144400

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:

• Lead the successful launch of new system placements , including hardware, catheters, and software.
• Assess individual and team training needs to ensure development and certification of EP mapping specialists through structured coaching and final assessments.
• Manage complex scheduling needs and resolve clinical coverage conflicts across geographic boundaries, providing hands-on clinical support and education as needed.
• Champion the introduction of new technologies and drive improvements in mapping utilization and clinical outcomes for existing customers.
• Collaborate closely with the EP Business Development Manager to align clinical goals and initiatives with the broader regional sales strategy.
• Foster a culture of collaboration through consistent communication with direct reports, peers, and leadership including EP Sales Reps, Rhythm Regional Managers, and the Area Sales Director.
• Oversee travel and expense reporting for your team, ensuring timeliness, accuracy, and adherence to company guidelines.
• Ensure compliance with all corporate policies and procedures while fostering a culture of integrity and accountability.
• Partner with key internal stakeholders —including Clinical Research, Marketing, Technical Support, and Sales—to deliver innovative solutions that meet customer needs.
• Lead ongoing education and skill development across the EP clinical team and support execution of company-sponsored events and trainings.
• Conduct performance reviews and provide feedback through regular field visits, mid-year, and annual evaluations.
• Maintain appropriate tools, resources, and staffing to ensure Quality System compliance and adherence to Boston Scientific’s Quality Policy.
• Promote an inclusive, high-performance work environment that encourages innovation, teamwork, and continuous improvement.
• Provide strategic oversight and guidance for budgets, team performance, and operational excellence across functional areas.
• Lead by example in promoting diversity, equity, and inclusion, enabling team members to contribute at their highest potential.
• Monitor adherence to regulatory and internal compliance standards , ensuring operational excellence across all activities.

Required qualifications:

• Minimum of a bachelor’s degree or an equivalent combination of education and professional background.
• Minimum of 7 years of related experience,
• Demonstrated business acumen with strong analytical and strategic thinking capabilities.
• Proven ability to build relationships and collaborate effectively with internal and external stakeholders across multiple divisions.

Preferred qualifications:

• Knowledge of the local EP customer base and regional market dynamics.
• EP certification and hands-on experience supporting electrophysiology therapies, implants, and related technologies.
• Established leadership presence with the ability to coach, influence, and develop high-performing teams.
• Strong conflict resolution and change management skills.
• Exceptional written and verbal communication abilities.
• Demonstrated success managing complex projects from concept to execution.
• Highly motivated, organized, and goal-driven with a strong sense of ownership.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.