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Hologic Lead Design Assurance Engineer in Marlborough, Massachusetts

We are growing our Design Assurance team! We are seeking a passionate and results driven Lead Design Assurance Engineer to join our Surgical Solutions division. We are excited to welcome a new teammate who leads by example and is committed to developing high quality products for our customers. There are many new and innovative products in the development pipeline that need the collaborative efforts of a high achieving individual, to set up the team for technical, compliance and commercial success.

In this role the lead will provide design assurance support for new product development and on market medical devices. This role will be responsible to facilitate 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.

Duties & Responsibilities:

  • Participate independently on new product development project, assuring product inputs are clearly defined 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 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.

Education

Technical Bachelor’s Degree

Experience

5+ years’ experience preferably in medical device industry

Skills

  • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive

  • Experienced with ISO 14970, 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 development of testable and measurable specifications

  • Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution

  • Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment

  • Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment

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.

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