Principal Software Design Assurance Engineer - Axonics Integration

Additional Location(s):  US-MN-Arden Hills; US-CA-Irvine; US-MA-Marlborough; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At 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 is an exciting opportunity for a software focused Principal Design Assurance Engineer supporting a cross-functional team on development and maintenance of Implantable and external devices and software within the Urology division. This position will support a significant product development project with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification and validation (V&V), risk management, product development, run the business, and regulatory and standards compliance. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This Design Quality role supports the active implantable design process for both existing and new products.

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. In this position, you can work in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA.

Relocation assistance is available for this position.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Your responsibilities include:

• Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V.
• Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation.
• Thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs).
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Update and maintain software risk management tools (i.e. Hazard Analysis, FMEAs).
• Participate in Cybersecurity related discussions and assist supporting activities including Security Risk Analysis.
• Lead and participate in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Assist in the design and development of software test cases and inspection procedures.
• Support regulatory submissions to notified bodies.
• 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.

What we’re looking for:
Required Qualifications

• Bachelor’s degree in mechanical, electrical, computer or biomedical engineering (or other related technical discipline)
• A minimum of 9 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Understanding of Software Development Life Cycle (SDLC)
• Experience with software testing and issue investigation/resolution
• Experience with Issue Tracking Tools and requirements / test management tools
• Understanding of software configuration management (version control, Microsoft office tools)
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
• Ability to work in a highly matrixed and geographically diverse business environment
• Demonstrated use of Quality tools/methodologies

Preferred qualifications

• Prior Software Design Assurance experience
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
• Experience in conducting and participating in code reviews

Requisition ID: 630910

Minimum Salary: $ 106800

Maximum Salary: $ 202900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see will 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.