Boston Scientific is looking to ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system for their Therasphere product line, ensuring product safety, reliability, and quality while complying with regulations and exceeding customer expectations.
Requirements
- Minimum of 5 years of Design Quality (AKA Design Assurance) engineering experience in a medical device or regulated environment or similar related work experience
- Experience with product that include Software or embedded firmware
- Complex problem solving
- Ability to be innovative and drive new perspectives based on industry standards and best practices
- Minimum 10 years experience in Medical devices
- Experience with Pharma
Responsibilities
- Oversee the continued organization and development of Therasphere Design Assurance team, providing Design Quality expertise and support for technical advancement, regulatory compliance, and operational systems and services throughout ongoing projects.
- Lead the growth and direction of the Design Assurance team dedicated to Therasphere.
- Work collaboratively with manufacturing partners, with a focus on the advancement of Therasphere operations within China.
- Responsible for the communication and documentation of internal information related to design quality assurance and compliance, as appropriate
- Applies effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving divisional design quality issues
- Leads the execution of streamlined quality systems and methodologies, which effectively identify and resolve design quality issues
- Keeps abreast of and act as an expert (within division) for current applicable worldwide regulatory & design quality assurance and compliance requirements
Other
- Minimum of a Bachelor's degree
- Minimum of 5 years of direct or indirect management experience
- Demonstrated ability to lead effectively across a broad set of cross functional partners/teams and diverse body of work/functions/sites in a highly matrixed environment
- 10% - 20% travel expectations
- Proven adaptability, comfortable with change and demonstrated ability to react and respond to a fast changing environment.
