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.

Sr. Design Assurance Manager -Sustaining Engineering

About the role:

We have an exciting opportunity for a Sustaining Engineering (SE) Sr. Design Assurance Manager to support the Peripheral Interventions (PI) division in Maple Grove.

Key responsibilities include:

• Driving functional excellence in Design Assurance SE by providing coaching and mentoring on product design change and material change best practices and ensuring technical excellence.

• Hiring, guiding, training and developing world-class staff to provide technical leadership for multiple sustaining projects.

• Provide leadership to implementation of EUMDR across the PI Division in partnership with Regulatory and Clinical.

• Working cross-functionally in identifying and resolving technical issues, takes a pro-active role in building bridges across the organization to mitigate issues.

• Driving and evaluating project and department progress, technical development plans, and results.

• Provide leadership and guidance to support the Quality initiatives including product performance based complaint reduction.

• Lead the DA SE team metrics, CAPA, shelf life, PMS and other initiatives to drive agile and efficient work.

• Interface with R&D and DA SE managers to provide prioritization of work for the DA team.

Management requirements:

• Lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and drive best practices throughout their organization.

• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

• Direct and control the activities and budget of one or more functional areas and/or projects/programs.

• Determines appropriate staff levels and schedules.

• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

What we’re looking for in you:

Minimum qualifications:

• Bachelor's degree plus 8-10 years of related work experience or an equivalent combination of education and work experience.

• Proven technical leadership and project management skills in medical device design, development and commercial launch.

• 5+ years of direct supervisory experience with a passion for leadership and team development

• Proven key leadership traits of: ability to be independent critical thinker, strong communication skills and ability to build effective cross-functional relationships

• Ability to interface with customers to gather insight and get organizational buy-in on key design inputs.

• Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations.

Preferred qualifications:

• B.S. Technical Degree such as Mechanical Engineering, Materials Science and/or Biomedical Engineering.

• Advanced degree in a technical field or business

• Understanding of risk management and design controls tools and requirements for medical device product development.

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: 452795