Design Assurance Engineer 3

Company: Hologic, Inc.
Location: Redwood City
Posted on: March 18, 2025

Job Description:

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effectively.Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.What to expect:

• Provide design assurance support for new product development and on-market medical devices. This role will be responsible for facilitating the application of design controls while supporting product development, manufacturing-related design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts.
• Participate independently in new product development projects, assuring product inputs are clearly defined and that design verification and validation activities are appropriate and compliant to confirm input requirements are met. Test method validation would be an element of assuring verification/validation is acceptable.
• Participate independently in sustaining product projects, ensuring the project is clearly defined and stays on task, confirming product inputs continue 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 products to assure compliance with applicable standards and internal policies.
• Responsible for independently coordinating the Health Risk Assessment team when needed for evaluation of on-market products, demonstrating efficient and effective analysis of situations, including problem definition and impact.
• Assess change requests of products for impact on design, determining supporting information required for implementation of changes.What we expect:
  • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive.
  • Experienced with ISO 14971, Risk Management.
  • Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
  • Working knowledge of verification and validation requirements for a regulated product.
  • Working knowledge of requirements analysis, including the development of testable and measurable specifications.
  • Ability to effectively work on project teams, including taking a leadership role 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 assessments.
  • Preferred:
    • Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment.Education & Experience:
      • Technical Bachelor Degree.
      • 2-5 years' experience, preferably in the medical device industry.The annualized base salary range for this role is $95,500 to $130,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.Agency and Third Party Recruiter Notice:Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.Redwood City, CA, United States, US, CA Employee
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Keywords: Hologic, Inc., Redwood City , Design Assurance Engineer 3, Engineering , Redwood City, California