Senior Design Assurance Manager - Cardiac Rhythm Management & Diagnostics

Boston Scientific • Arden Hills, MN

296d • $122,100 - $232,000

About The Position

Boston Scientific is currently recruiting a Senior Design Assurance Manager to lead our team at the Arden Hills, MN location in the Cardiac Rhythm Management & Diagnostics (CRMDx) division. This is an exciting and rewarding opportunity to lead the Design Assurance team, in collaboration with our cross-functional partners, developing and sustaining lifesaving and life-enhancing technologies for patients with rhythm disorders and heart failure from diagnosis to treatment, including Cardiac Implantable Electronic Device (CIED) systems, Medical Electrical Equipment (MEE), Remote Patient Monitoring (RPM) systems, and Single Use Devices (SUDs). The Senior Design Assurance Manager will drive the team to ensure product quality and conformance to global standards and regulations through the application of Design Control and Risk Management, while leading with a keen focus on patient safety and reliable product performance, in close partnership with Research & Development, Regulatory, Medical, Marketing, Manufacturing Engineering, and Project Management.

Requirements

• 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 supervisory experience with a passion for leadership and team development.
• Medical Device or regulated industry experience.

Nice To Haves

• Bachelor's degree in engineering.
• Advanced degree in science, engineering, or business.
• Experience leading technical teams.
• R&D experience.
• Design Controls and Risk Management experience.
• FDA/ISO Medical Device Regulations experience.

Responsibilities

• Leads a team of employees in the achievement of organizational goals, project goals, and career goals.
• Recruits, hires, supports, and develops a high performing team.
• Leads Design Assurance team through product development and sustainment projects of major magnitude and scope, including the completion of functional deliverables and serving as the voice of Quality, supporting technical excellence across the project.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Develops and implements quality strategies; seeks innovative approaches to achieving quality goals.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Maintains and enhances cross-functional partner relationships.
• Develops department budget and monitors spending.
• Determines appropriate staff levels and schedules.
• Works with cross-functional partners to understand priorities and plans resource allocation accordingly.
• Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• May serve as liaison between the company and the various governmental agencies worldwide.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Benefits

• 401k
• 401k_matching
• dental_insurance
• health_insurance
• life_insurance
• paid_holidays
• tuition_reimbursement
• wellness_programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree