Senior Design Assurance Manager- Interventional Cardiology (IC) Job
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Date: Feb 15, 2021
Location: Maple Grove, MN, US, 55311
Company: Boston Scientific
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Boston Scientific is currently recruiting for a Sr. Design Assurance Manager to lead a team in our Maple Grove MN location. This is an exciting opportunity to lead a team in sustaining and developing of medical electrical equipment with specific focus on mechanical and electrical elements. You will work with your R&D, PD and Manufacturing peers on current and future Interventional Cardiology (IC) products/systems in this rapidly growing division of BSC.
This role will provide DA leadership for Hardware and Software development and sustaining for the IC business and lead a team of skilled Engineers and Technicians. You will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management and is a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving new product development, commercialization and product sustainment.
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:
Minimum qualifications:
- Bachelor's degree plus 7-9 years of related work experience or an equivalent combination of education and work experience.
- 5+ years of direct supervisory experience with a passion for leadership and team development.
- Medical Device or regulated industry experience.
- Understanding of applicable electrical safety standards and configuration management
- Experience in reliability testing
Preferred qualifications:
- Experience leading technical teams
- Prior R&D experience
- Advanced degree in a technical field or business
- Regulatory compliance experience in the areas of medical devices, combination products, pharmaceuticals, and analytical methodology
About us
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 472853
Nearest Major Market: Minneapolis
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