Product Development Assurance Specialist

hace 4 días

Alajuela, Alajuela, Costa Rica Hologic, Inc. A tiempo completo

Job Summary:

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This role requires a highly skilled Design Assurance Engineer to participate in new product development and sustaining projects. The incumbent will be responsible for ensuring product inputs are clearly identified, design verification and validation activities are appropriate, and compliance with applicable standards and internal policies is maintained.

About Us:

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Hologic, Inc. is a leading global medical technology company focused on improving women's health and well-being through early cancer detection and treatment. Our products and solutions address the needs of patients, healthcare professionals, and payers worldwide.

Responsibilities:

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The Design Assurance Engineer will:

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  • Participate independently on new product development projects, assuring product inputs are clearly identified and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met.">
  • Test method validation would be an element of assuring verification/validation is acceptable.">
  • Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.">
  • Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.">
  • Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on-market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.">
  • Assess change requests of product for impact to design, determine supporting information required for implementation of changes.">
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Requirements:

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To be successful in this role, you will need:

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  • A Bachelor degree, with a master's degree desirable.">
  • A minimum of 5 years' experience, preferably in the medical device industry.">
  • Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485, and Medical Devices Directive.">
  • Working knowledge of ISO 14971, Risk Management, and familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.">
  • Ability to effectively work on project teams, including taking leadership roles on critical tasks to assure appropriate and timely completion/resolution.">
  • Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment.">
  • Fluent English language skills, with Spanish language skills desirable.">
  • Microsoft Office Tools proficiency.">
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What We Offer:

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We offer a competitive salary range of $120,000 - $150,000 per year, depending on experience, plus benefits, and opportunities for career growth and professional development.

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