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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
About the role:This Principal Software Design Quality Engineer position will support active implantable medical devices. This position serves as a leader in design controls, software verification and validation (V&V), risk management, cybersecurity, and regulatory compliance for complex medical devices. In this role, you will partner with cross-functional leaders to influence product and process decisions, guide risk-based approaches, and mentor other engineers to elevate design quality capabilities across the organization.
Work Mode:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
Relocation Assistance:Relocation assistance is not available for this position.
Visa Sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.
Your responsibilities will include: - Serve as the primary software design quality lead for complex and strategic product development initiatives, from concept through commercialization.
- Drive and oversee implementation of risk management processes (ISO 14971), including hazard analysis, software FMEAs, and security risk analysis, ensuring integration into the development process.
- Develop and maintain software risk management tools (Hazard Analysis, FMEAs) with traceability to requirements, design, and test artifacts.
- Collaborate with cybersecurity teams to ensure compliance with evolving security requirements and integrate security risk management into the product lifecycle.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices.
- Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
- Support Post Market activities, as necessary, of risk based on post-market signals.
- Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
- Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
- Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
- Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What we're looking for in you: Required qualifications:
- Bachelor's degree in engineering, computer science, or related technical discipline and 9+ years of experience in design quality, software quality, new product development or related medical device/regulated industry roles, with a focus on software-intensive products.
- Proven expertise in Software Development Life Cycle (SDLC), risk management, and software verification and validation.
- Extensive experience with software quality tools, issue tracking (e.g., JIRA), and requirements/test management platforms.
- In-depth understanding of software configuration management, version control systems, and related quality controls.
- Demonstrated ability to lead cross-functional initiatives, influence without direct authority, and make strategic quality decisions.
- Exceptional verbal and written communication skills, with experience presenting to leadership and external regulatory bodies.
- Strong analytical and problem-solving skills, with a record of resolving complex quality issues.
Preferred qualifications:
- Experience working with medical electrical equipment and/or active implantable devices.
- Comprehensive knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and related software standards.
- Background in embedded software, systems engineering, or integration of hardware and software systems.
- Adaptable and effective collaborator in a team environment or in self-directed work.
- Experience with design changes, complaint reduction, and corrective action.
- Experience in code review practices and secure coding principles.
- Experience working with medical equipment comprised of several devices (e.g., active implantable, programmer, mobile monitor, and remote monitoring web-based digital platform).
Requisition ID: 636158 Minimum Salary: $ 102100 Maximum Salary: $ 194000 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for
non-exempt (hourly), non-sales roles may 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 for
exempt, non-sales roles may 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.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on LinkedIn.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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.
