Boston Scientific Design Assurance Director 

United States, Massachusetts, Waltham 

293573563

Your key responsibilities will include:

• Recruit, coach and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team.
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership.
• Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture.
• Develop and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, ISO, etc.).
• Lead quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects.
• Own and drive 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.
• Own and drive commercial product monitoring and all related product sustainment activities.
• Develop and implement quality strategies; seeks innovative approaches to attaining quality goals.
• Directly interface with internal and external audit activities.

Required Qualifications:

• Minimum of a Bachelors degree
• Minimum of 10 years of related experience
• Minimum of 5 years of direct or indirect management experience
• Regulatory compliance experience in the areas of medical devices

Preferred Qualifications:

• Advanced degree in technical fields
• Experience leading technical teams
• Prior R&D, Design Assurance, Product and/or Process Development, Capital Equipment experience

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.