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Boston Scientific · 1 day ago

Senior Software Design Assurance Engineer

Maple Grove, MN

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $157K/yr

5+ years exp

Boston Scientific is a leader in medical science committed to solving important health industry challenges. The Senior Software Design Assurance Engineer will support a cross-functional team in the development and maintenance of capital equipment and software, ensuring compliance with design controls and regulatory standards while protecting patient safety.

Health CareMedicalMedical Device

No H1B

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

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)

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

Participate in Cybersecurity related discussions and assist supporting activities

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

Qualification

Software Development Life Cycle (SDLC)Risk Management (ISO 14971)Quality System Regulation (QSR)Software VerificationValidation (V&V)Software TestingIssue Tracking Tools (JIRA)Software Configuration ManagementProblem-Solving MethodologiesCommunication SkillsTeam Collaboration

Required

Bachelor's degree in engineering, or related discipline related field of study

A minimum of 5 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 (JIRA) 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

Ability to travel up to 25%

Preferred

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

Benefits

Relocation assistance is available for this position.

Compensation 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).