Design Assurance Manager

Boston Scientific Gruppe; Maple Grove (MN); Hybrid; USD 99,000 - 189,000; Full time

Job summary

Boston Scientific seeks a Design Assurance Manager in Maple Grove, MN. This role focuses on developing and maintaining single-use medical devices, ensuring product quality and compliance. The ideal candidate will have leadership experience in regulated industries, including medical devices.

Qualifications

• At least 5 years of related experience or equivalent combination.
• Minimum 2 years of supervisory experience.

Responsibilities

• Leading quality efforts on major product/system development projects.
• Ensuring technical excellence in product development.
• Managing Design Controls and Quality activities.

Skills

Leadership

Regulatory Compliance

Risk Management

Quality Assurance

Education

Bachelor's degree

Job description

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we offer opportunities to work with diverse, high-performing teams tackling key health industry challenges. With access to cutting-edge tools, information, and training, we support your skill and career growth. We foster a supportive environment for your ambitions.

About the role:

Boston Scientific is recruiting a Design Assurance Manager for our Maple Grove, MN location. This role involves leading a team in developing and maintaining single-use devices for medical electrical equipment/systems (MEE).

The Design Assurance Manager will oversee Design Assurance for Single Use Devices and sustainment within the Interventional Cardiology (IC) division, leading Engineers and Technicians. Responsibilities include ensuring product quality and compliance via Design Control and Risk Management, collaborating with R&D, Regulatory, Marketing, and Manufacturing teams to support product development, launch, and sustainment in a rapidly growing division.

This role requires a hybrid work model, with at least three days per week in the Maple Grove office. Boston Scientific will not sponsor or transfer employment visas for this position. Limited relocation assistance is available.

Your responsibilities include:

• Leading quality efforts on major product/system development projects, serving as the key quality voice.
• Ensuring technical excellence in product development and functional deliverables.
• Managing Design Controls, Risk Management, Product Performance, Quality, and Compliance activities, including V&V and failure investigations.
• Overseeing product monitoring and sustainment activities.
• Developing and implementing quality strategies, seeking innovative approaches.
• Guiding and training staff, supporting career development, motivating results, and recruiting high-quality personnel.
• Managing department budget and resources.
• Maintaining cross-functional relationships and resolving technical issues.
• Leading a team towards organizational goals, coaching, directing, and developing team members.
• Promoting diversity in the workplace.
• Ensuring compliance with policies and regulatory requirements.
• Interfacing with audit activities.

Qualifications:

• Bachelor's degree required
• At least 5 years of related experience or equivalent combination
• Minimum 2 years of supervisory experience with leadership passion
• Experience in Medical Devices or regulated industries

Preferred:

• Advanced degree in technical or business fields
• Experience leading technical teams and R&D
• Regulatory compliance experience in medical devices, pharmaceuticals, or related areas
• Knowledge of electrical safety standards and configuration management
• Experience in reliability testing

Requisition ID: 608191

Salary Range: $99,100 - $188,300

The actual compensation will vary based on location, experience, education, and organizational needs. Boston Scientific does not typically hire at the salary range extremes.

Additional compensation may include bonuses, incentives, and overtime, depending on role classification.

Note: For MA positions, it is unlawful to require or administer lie detector tests.

Boston Scientific is committed to diversity, inclusion, and equal opportunity employment. We promote a workplace that reflects the communities we serve.

COVID-19 vaccination proof may be required for certain roles, and candidates will be informed during the interview process. The company complies with all applicable laws regarding vaccination and drug testing for safety-sensitive positions.

Nearest Major Market: Minneapolis

Job Segment: Medical Device, Compliance, Marketing Manager, R&D Engineer, Healthcare, Engineering