Job Description

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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes 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 were 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 youre looking to truly make a difference to people both around the world and around the corner, theres 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