Boston Scientific Software Supplier Quality Engineer III 

United States, Minnesota, Arden Hills 

140129046

Matthew Paul Herlofsky
Spencer Gregory Hale

Your responsibilities include:

Supplier Management:

• Evaluate and select software suppliers based on their capabilities, quality systems, and adherence to industry standards.
• Establish strong relationships with suppliers, fostering open communication and collaboration.
• Conduct regular supplier audits to assess their quality management processes.

Quality Assurance:

• Review and approve software-related documentation, including design specifications, test plans, and risk assessments.
• Ensure that software development processes comply with relevant standards (e.g., ISO 13485, IEC 62304).
• Monitor software change control processes and assess their impact on product quality.

Risk Management:

• Participate in risk assessments related to software components.
• Identify potential risks associated with software design, development, and maintenance.
• Work with suppliers to mitigate risks and implement effective corrective actions.

Supplier Development:

• Collaborate with suppliers to improve their software development practices.
• Provide guidance on best practices, quality methodologies, and regulatory requirements.
• Facilitate training sessions for suppliers to enhance their understanding of medical device software quality.

Product Lifecycle Support:

• Ensure that software-related changes are properly documented and validated.
• Review and approve software validation protocols and reports.
• Support post-market surveillance activities related to software issues.

Cross-Functional Collaboration:

• Work closely with software development teams, quality assurance, regulatory affairs, and other stakeholders.
• Participate in design reviews, risk assessments, and project meetings.

Continuous Improvement:

• Drive continuous improvement initiatives within the software supply chain.
• Analyze data, track key performance indicators, and identify areas for enhancement.
• Implement corrective and preventive actions to address quality gaps.

What we’re looking for:

Basic Qualifications

• Bachelor’s degree in biomedical engineering, computer science, software engineering, or a related field.
• Minimum of 4 years of experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
• Experience in software quality assurance, supplier management, or regulatory compliance within the medical device industry.

Preferred Qualifications

• Certification in quality management (e.g., ASQ Certified Quality Engineer) is advantageous.
• Proficiency in relevant standards (e.g., ISO 13485, IEC 62304, FDA regulations).
• Strong analytical skills, attention to detail, and problem-solving abilities.
• Excellent communication and interpersonal skills.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.