Medical Device Design Assurance Leader
hace 3 días
Company Overview
Boston Scientific Corporation is a leading medical device manufacturer that values innovation, diversity, and inclusivity. We strive to create a collaborative culture that fosters growth and improvement in people's lives.
About the Role
This position involves leading cross-functional teams through product life cycles, ensuring project success by working with R&D, project management, manufacturing, regulatory, clinical, and marketing departments.
Key Responsibilities
- Work cross-functionally to ensure project success
- Understand device performance and anatomy interaction, identifying opportunities for device and procedure improvements
- Determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
- Maintain product risk management documentation (Hazard Analysis, Fault Tree, FMEAs)
- Develop and coordinate Design Validation and Verification activities
- Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
- Lead CAPA, NCEP, Complaints, Failure Mode Investigations, etc.
- Expertise in validation and statistical techniques to comply with regulatory requirements
Estimated Salary
$115,000 - $145,000 per year
Required Qualifications
- Bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical, or related field
- Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development, or related medical device experience
- ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
- English language proficiency: 80-89%
Preferred Qualifications
- Self-motivated with a passion for solving problems
- Ability to manage multiple priorities and work with ambiguity
- Strong communication skills (verbal & written)
- Proficiency in collaborating with interdisciplinary teams
Benefits
Boston Scientific offers a comprehensive benefits package, including career growth opportunities, community involvement, and a collaborative work environment.
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