Senior Design Assurance Manager - Interventional Cardiology

Boston Scientific; Maple Grove (MN); On-site; USD 122,000 - 232,000; Full time

Job summary

An established industry player is seeking a Senior Design Assurance Manager to lead a high-performing team in developing medical electrical equipment. This role involves overseeing quality assurance processes, managing risk, and ensuring compliance with industry standards. You will guide a team dedicated to innovation and excellence, fostering a diverse workplace where every member can thrive. Join a company that values collaboration and is committed to improving patient health through cutting-edge technology. This is an exciting opportunity to make a significant impact in a dynamic environment while advancing your career in the medical device field.

Qualifications

• 7+ years of related work experience in the medical device industry.
• 5+ years of management experience with a focus on team development.

Responsibilities

• Lead quality team on major product/system development projects.
• Develop and implement quality strategies; ensure compliance with regulations.

Skills

Leadership

Quality Assurance

Risk Management

Regulatory Compliance

Team Development

Education

Bachelor's degree

Advanced degree in technical field or business

Job description

Additional Location(s): N/A

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

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. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
Boston Scientific is currently recruiting for a Senior Design Assurance Manager to lead a team in our Maple Grove MN location. This is an exciting opportunity to lead a team in developing and sustaining medical electrical equipment/systems (MEE) with IVUS imaging.

Your responsibilities include:

• Leads quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects.
• Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
• Owns and drives commercial product monitoring and all related product sustainment activities.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals.
• Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
• Develops department budget and monitors spending.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Lead a team of employees in the achievement of organizational goals. Coach, direct, and develop a high performing team.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

What we're looking for in you:
Required Qualifications:

• Minimum of a Bachelor's degree
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Minimum of 5 years of direct or indirect management experience with a passion for leadership and team development
• Medical Device or regulated industry experience

Preferred Qualifications:

• Advanced degree in technical field or business
• Experience leading technical teams
• Prior R&D experience
• Regulatory compliance experience in the areas of medical devices, combination products, pharmaceuticals, and analytical methodology
• Understanding of applicable electrical safety standards and configuration management
• Experience in reliability testing

Requisition ID:601143

Minimum Salary:$122100

Maximum Salary: $232000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.