Senior Design Assurance Expert
hace 2 meses
About the Role
">We are seeking an experienced Senior Design Assurance Expert to join our team at Boston Scientific Corporation. In this role, you will be responsible for ensuring project success through cross-functional collaboration with R&D, project management, manufacturing, regulatory, clinical, and marketing teams.
">Key Responsibilities
">- ">
- Work closely with stakeholders to understand device performance and anatomy interaction, identifying opportunities for device and procedure improvements.">
- Lead the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.">
- Maintain product risk management documentation, including Hazard Analysis, Fault Tree, and FMEAs.">
- Apply expertise in validation and statistical techniques to ensure compliance with regulatory requirements and internal standards.">
- Collaborate with interdisciplinary teams to drive project success.">
Requirements
">To be successful in this role, you will need:
">- ">
- A bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical, or a related field of study.">
- English language proficiency (80-89%).">
- Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development, or related medical device experience.">
- Strong understanding of ISO 13485, ISO 14971, and Quality System Regulations, with a focus on Design Controls and Risk Analysis.">
- Excellent communication and problem-solving skills, with the ability to manage multiple priorities and work effectively in a fast-paced environment.">
What We Offer
">As a Senior Design Assurance Expert at Boston Scientific Corporation, you can expect:
">- ">
- A competitive salary range of $120,000 - $180,000 per year, based on location and experience.">
- A comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.">
- Opportunities for professional growth and development in a dynamic and innovative company.">
- A collaborative and inclusive work environment, with a focus on diversity, equity, and inclusion.">
Location
">This role is based in Heredia, CR, with opportunities for remote work and travel as needed.
">Estimated Salary: $142,500 per year
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