Senior Design Assurance Manager, Interventional Oncology

3 weeks ago

Maple Grove, United States Boston Scientific Full time

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, integrating, and sustaining of single use embolic device.


The Senior Design Assurance Manager will provide Design Assurance leadership for Single Use Device New Product Development and Integration for the Peripheral Interventions (PI) Interventional Oncology & Embolization business and will lead a team of skilled engineers. This Senior Design Assurance Manager will be responsible for ensuring product quality and compliance, leading the application of Design Control and Risk Management. This Senior Design Assurance Manager will be a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving new product development, commercialization, and product sustainment within Peripheral Intervention Division of Boston Scientific

Your responsibilities include:

  • Leads quality team on product 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.
  • Partners with Sustaining to support commercial product monitoring and all related product sustainment activities.
  • Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
  • Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • 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.
  • 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 8 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 commercialization
  • Proven independent critical thinker, strong communication skills, strong presentation 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 of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
  • Medical Device or regulated industry experience


Preferred qualifications:

  • BS in an engineering discipline
  • Advanced degree in technical field or business.
  • Experience leading technical teams.
  • Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
  • Familiarity with BSC products and customer needs


Hybrid: Based out of Maple Grove, MN required.

Area Supporting: Interventional Oncology

  • Senior Design Assurance Manager, Interventional Oncology

    3 weeks ago

    Maple Grove, United States Boston Scientific Full time

    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, integrating, and sustaining of single use embolic device.The Senior Design Assurance Manager will provide Design Assurance leadership for Single Use Device New Product...

  • Senior Design Assurance Manager

    2 weeks ago

    Maple Grove, United States Boston Scientific Full time

    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, integrating, and sustaining of single use embolic device. The Assurance, Manager, Design, Product Development, Manufacturing Engineer, Senior, Business Services

  • Senior Design Assurance Manager- Structural Heart

    1 month ago

    Maple Grove, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...

  • Senior Design Quality Manager

    3 weeks ago

    Maple Grove, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...

  • Senior Design Assurance Product Performance Engineer

    6 days ago

    Maple Grove, United States Boston Scientific Full time

    Work mode: HybridOnsite Location(s): Maple Grove, MN, US, 55311Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...

  • Senior Design Assurance Product Performance Engineer

    6 days ago

    Maple Grove, United States Boston Scientific Full time

    Work mode: HybridOnsite Location(s): Maple Grove, MN, US, 55311Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...

  • Design Assurance Engineer III

    3 months ago

    Maple Grove, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...

  • Design Assurance Engineer

    1 month ago

    Maple Grove, United States Talent Software Services Full time

    Design Assurance Engineer Job Summary: Talent Software Services is in search of a Design Assurance Engineer for a contract to hire position in Maple Grove, MN. Position Summary: The Design Assurance Engineer is a quality engineer who directly supports medical device product development from concept through commercialization. The employee will work with a...

  • Design Assurance Engineer

    1 month ago

    Maple Grove, United States TALENT Software Services Full time

    Are you an experienced Design Assurance Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Design Assurance Engineer to work at their company in Maple Grove, MN.Position Summary: The Design Assurance Engineer is a quality engineer who directly supports medical device product...

  • Design Assurance Engineer

    1 month ago

    Maple Grove, Minnesota, United States Advantage Technical Full time

    We are seeking a highly motivated Design Assurance engineer for our Global Medical Device client. About the role: The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional sustaining team to ensure safety,...

  • Design Assurance Engineer I

    1 month ago

    Maple Grove, United States US Tech Solutions Full time

    Duration: 06+ Months Contract (Possible Extension) Duties:Hybrid – Three Days in office.Job PurposeThe Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional team to ensure safety, quality and compliance...

  • Design Assurance Engineer I

    1 month ago

    Maple Grove, United States US Tech Solutions Full time

    Duration: 06+ Months Contract (Possible Extension) Duties:Hybrid – Three Days in office.Job PurposeThe Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional team to ensure safety, quality and compliance...

  • Senior Design Quality Engineer

    1 month ago

    Maple Grove, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...

  • Caregiver (PM Shift) - Beautiful New Senior Living Community

    3 months ago

    Maple Grove, United States Suite Living Senior Care Full time

    Job DescriptionJob DescriptionPOSITION: CAREGIVERCOMPANY: Suite Living Senior CareLOCATION: Maple Grove, MNTYPE: PT and FT AvailableSHIFT(S) AVAILABLE: PM (2pm-10pm)BENEFITS: We offer Blue Cross Blue Shield Medical Plans, Dental, PTO, Paid Holidays, company paid Life and Long-Term Disability, 401k with up to 3% company match.We are seeking Caregivers to join...

  • Caregiver (PM Shift) - Beautiful New Senior Living Community

    3 weeks ago

    Maple Grove, United States Suite Living Senior Care Full time $18 - $20

    Job DescriptionJob DescriptionPOSITION: CAREGIVERCOMPANY: Suite Living Senior CareLOCATION: Maple Grove, MNTYPE: PT and FT AvailableSHIFT(S) AVAILABLE: PM (2pm-10pm)BENEFITS: We offer Blue Cross Blue Shield Medical Plans, Dental, PTO, Paid Holidays, company paid Life and Long-Term Disability, 401k with up to 3% company match.We are seeking Caregivers to join...

  • Senior Product Manager, Customer Engagement

    7 days ago

    Maple Grove, Minnesota, United States Boston Scientific Full time

    About the Role:The Senior Product Manager, Customer Engagement will support the Coronary Therapies franchise, owning the development and execution of the strategic and tactical customer engagement plan, and related high-level initiatives designed to enable VOC to inform business strategy and decision making.This role will actively engage & partner with...

  • Engineering Quality Assurance Specialist

    2 weeks ago

    Maple Grove, Minnesota, United States TALENT Software Services Full time

    Welcome to Talent Software ServicesPosition Overview: We are seeking a proficient Design Assurance Engineer to enhance our client's team. In this role, you will be pivotal in formulating, executing, and sustaining quality engineering practices that align with client, customer, and regulatory expectations. You will act as a Quality representative, fostering...

  • Senior Commercial Data Analyst, PI

    3 months ago

    Maple Grove, Minnesota, United States Boston Scientific Full time

    Additional Location(s):US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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...

  • Lead Engineer, Design Quality

    3 months ago

    Maple Grove, United States Celestica Full time

    Req ID: 118972 Region: Americas Country: USA State/Province: Minnesota City: Maple Grove **General Overview** **Job Title:** Senior Lead Engineer, Design Quality **Functional Area:** Engineering (ENG) **Career Stream:** Design Quality Engineering **Role:** Senior Lead Engineer **Job Code:** ADV-ENG-DQE **Job Band:** 09 **Direct/Indirect Indicator:** Indirect...

  • Lead Engineer, Design Quality

    6 days ago

    Maple Grove, United States Celestica Full time

    Req ID: 118972 Region: Americas Country: USA State/Province: Minnesota City: Maple Grove General Overview Job Title: Senior Lead Engineer, Design Quality Functional Area: Engineering (ENG) Career Stream: Design Quality Engineering Role: Senior Lead Engineer Job Code: ADV-ENG-DQE Job Band: 09 Direct/Indirect Indicator: Indirect Summary Your new challenge:...