Senior Design Assurance Expert

hace 2 meses


San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

About the Role

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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.

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Key Responsibilities

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  • 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.">
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Requirements

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To be successful in this role, you will need:

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  • 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.">
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What We Offer

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As a Senior Design Assurance Expert at Boston Scientific Corporation, you can expect:

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  • 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.">
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Location

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This role is based in Heredia, CR, with opportunities for remote work and travel as needed.

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Estimated Salary: $142,500 per year



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