Design Quality Manager - Interventional Oncology & Embolization

Design Quality Manager - Interventional Oncology & Embolization

The Boston Scientific Interventional Oncology & Embolization (IO&E) organization is the market leader in therapeutics and tools for interventional radiologists, featuring Y90 microspheres, ablation devices, embolic devices and a selection of ancillary products. We are looking for a dynamic Design Quality Manager to lead a team of engineers supporting the growing TheraSphere Y90 franchise. In this role you will work with high-performing cross-functional Sustaining Engineering and New Product Development teams to maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN and requires being on-site at least three days per week.

Your responsibilities will include:

• Assists in and/or manages functional deliverables and ensures technical excellence for Sustaining Engineering and New Product Development.
• Drives functional excellence in Design Quality Assurance by providing leadership, coaching, and mentoring on product design and development, including Risk Management, Design Controls, and Post-Market Surveillance.
• Provides leadership, guidance, and approval regarding Quality initiatives including product performance.
• Reviews and approves verification and validation plans, protocols, reports, and non-conforming product assessments.
• Works cross-functionally in identifying and resolving technical issues, takes a proactive role in collaborating across the organization to mitigate issues.
• Works with project managers and functional leaders (R&D, Supplier Quality Engineering, Marketing, and Regulatory) to understand priorities, plan resources, and allocate time.
• Explores opportunities for staff to learn about new initiatives and participate on new projects.
• Drives and evaluates process and results for project and department objectives.
• Recruits, hires, trains, and develops world-class staff.

Management requirements:

• Leads 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.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Directs and controls the activities and budget of one or more functional areas and/or projects/programs.
• Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Influences others to build collaborative relationships, achieve goals and effectively guide them to understand more complex issues.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we're looking for in you:

• B.S. Degree in engineering such as Mechanical Engineering, Electrical Engineering, Materials Science and/or Biomedical Engineering.
• Bachelor's degree plus 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, commercial launch, and product sustainment.
• Knowledge/Experience of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
• 2+ years of experience mento.