Principal Software Design Quality Engineer at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software Design Quality, Risk Management, Software Verification, Validation Strategies, Data-Driven Decision Making, Regulatory Compliance, Technical Documentation, Software Quality Tools, Cross-Functional Leadership, Analytical Skills, Problem-Solving, FDA Regulations, ISO Standards, Embedded Software, Cybersecurity, Software Development Life Cycle

Industry

Medical Equipment Manufacturing

Description

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. Lead development and execution of comprehensive software V&V strategies to ensure robust, compliance, and efficient testing aligned with IEC 62304 and other applicable standards. Provide expert guidance on system and software design controls, leading design reviews, software bug triage, and field issue investigations with a focus on systemic corrective actions. Champion the use of data-driven decision-making and advanced problem-solving methodologies to resolve quality issues and mitigate risks. Act as a regulatory and standards subject matter expert, contributing to regulatory strategy, authoring, and reviewing technical documentation for submissions, and representing software quality in audits and inspections. Develop and maintain software risk management tools (Hazard Analysis, FMEAs) with traceability to requirements, design, and test artifacts. Mentor and coach junior and senior engineers in software quality principles, risk management, and design controls. Collaborate with cybersecurity teams to ensure compliance with evolving security requirements and integrate security risk management into the product lifecycle. Partner with product development, systems engineering, and regulatory affairs to implement best practices and process improvements that enhance product safety and compliance. Foster a culture of quality and continuous improvement across cross-functional teams. 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. Bachelor's degree in engineering, computer science, or related technical discipline and 9+ years of experience in design quality, software quality, or related medical device/regulated industry roles, with a focus on software-intensive products. Master's degree in engineering, computer science, or related technical discipline and 7+ years of experience in design quality, software quality, 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. Ability to travel up to 25% Comprehensive knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and related software standards. Experience with global regulatory submissions and interacting with notified bodies or FDA. Background in embedded software, systems engineering, or integration of hardware and software systems. Experience in code review practices and secure coding principles. Advanced degree in engineering, computer science, or related field.

Responsibilities

Serve as the primary software design quality lead for complex product development initiatives, overseeing risk management processes and software verification strategies. Mentor engineers and collaborate with cross-functional teams to enhance product safety and compliance.