Boston Scientific Gruppe
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance
At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
Hybrid Roles Boston Scientific's hybrid workplace includes Working from Home and onsite. You will have the opportunity to discuss details in the interview.
About the role The Design Assurance Manager will provide Design Assurance leadership for Single Use Devices for the Peripheral Interventions business and will lead a team of skilled engineers. This Design Assurance Manager will be responsible for ensuring product quality and compliance, leading the application of Design Control and Risk Management. This Design Assurance Manager will be a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving product sustainment within Peripheral Intervention Division of Boston Scientific
Your Responsibilities Include
Leads quality team in sustaining activities to support commercial product monitoring on 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.
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
Minimum of a Bachelor's degree in Chemical, Biotechnology, Materials Science, Mechanical, Mechatronic or related field.
Minimum of 6 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
#CRTA #CRGH #MANCR
Requisition ID: 612707
Job Segment: R&D Engineer, Risk Management, Manufacturing Engineer, R&D, Materials Science, Engineering, Finance, Research, Science
#J-18808-Ljbffr
At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
Hybrid Roles Boston Scientific's hybrid workplace includes Working from Home and onsite. You will have the opportunity to discuss details in the interview.
About the role The Design Assurance Manager will provide Design Assurance leadership for Single Use Devices for the Peripheral Interventions business and will lead a team of skilled engineers. This Design Assurance Manager will be responsible for ensuring product quality and compliance, leading the application of Design Control and Risk Management. This Design Assurance Manager will be a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving product sustainment within Peripheral Intervention Division of Boston Scientific
Your Responsibilities Include
Leads quality team in sustaining activities to support commercial product monitoring on 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.
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
Minimum of a Bachelor's degree in Chemical, Biotechnology, Materials Science, Mechanical, Mechatronic or related field.
Minimum of 6 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
#CRTA #CRGH #MANCR
Requisition ID: 612707
Job Segment: R&D Engineer, Risk Management, Manufacturing Engineer, R&D, Materials Science, Engineering, Finance, Research, Science
#J-18808-Ljbffr