Boston Scientific
Software Design Quality Engineer II
Boston Scientific, Osseo, Minnesota, United States, 55311
Software Design Quality Engineer II – Boston Scientific
Join to apply for the
Software Design Quality Engineer II
role at
Boston Scientific .
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.
About the Role This is 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. The role will support a significant product development project with high visibility that will provide excellent growth potential and product development experience.
The engineer will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification & validation (V&V), risk management, product development, and regulatory and standards compliance. They will maintain strong collaborative partnerships with cross‑functional team members to protect patient/user safety and meet business needs.
The role will actively participate in all aspects of Design Control including system and software, serve 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.
The position requires a hybrid work model with employees in the Maple Grove office at least three days per week. Relocation assistance is available. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your Responsibilities
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.
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 Requirements/ Test Management Tools
Knowledge of Cybersecurity and Cloud Computing concepts
Knowledge of Artificial Intelligence/ Machine Learning concepts
Boston Scientific Corporation is an equal opportunity employer. We are committed to nurturing a diverse and inclusive workplace and do not discriminate on the basis of race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, age, disability, or any other protected class.
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Software Design Quality Engineer II
role at
Boston Scientific .
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.
About the Role This is 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. The role will support a significant product development project with high visibility that will provide excellent growth potential and product development experience.
The engineer will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification & validation (V&V), risk management, product development, and regulatory and standards compliance. They will maintain strong collaborative partnerships with cross‑functional team members to protect patient/user safety and meet business needs.
The role will actively participate in all aspects of Design Control including system and software, serve 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.
The position requires a hybrid work model with employees in the Maple Grove office at least three days per week. Relocation assistance is available. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your Responsibilities
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.
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 Requirements/ Test Management Tools
Knowledge of Cybersecurity and Cloud Computing concepts
Knowledge of Artificial Intelligence/ Machine Learning concepts
Boston Scientific Corporation is an equal opportunity employer. We are committed to nurturing a diverse and inclusive workplace and do not discriminate on the basis of race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, age, disability, or any other protected class.
#J-18808-Ljbffr