Software Design Quality Engineer II

Additional Location(s): N/ADiversity – 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: We have an exciting opportunity for a software-focused Design Quality (or Design Assurance) Engineer II supporting a cross‑functional team on development and maintenance of capital equipment firmware and software within the Interventional Cardiology (IC) 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, 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 role will actively participate in all aspects of Design Control including systems and software.

Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove office at least three days per week. Relocation assistance is available for this position.

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

• 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.
• 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
• Assist in the design and development of software test methods 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 computer science, computer engineering, or related discipline

• Minimum of 3 years of experience in design assurance, quality, new product development, or related medical device/regulated industry

• Understanding of Software Development Lifecycle (SDLC)

• Understanding of software testing and issue investigation/ resolution

• Understanding of software configuration management (version control, Microsoft office tools)

• Knowledge of analytical techniques, problem solving and process improvement

• Strong written/verbal communication skills

Preferred qualifications:

• Prior Software Design Assurance or related experience is a plus

• 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 with Software code reviews

• Experience with Issue Tracking Tools (i.e. JIRA) and…