• Quality Design Engineer II

    Hologic (Newark, DE)


    Quality Design Engineer II

     

    Newark, DE, United States

     

    Marlborough, MA, United States

     

    Are you passionate about driving quality improvements and ensuring the safety and reliability of life-changing medical devices? At Hologic, we are seeking a **Quality Design Engineer II** to lead design changes, product enhancements, and quality projects while ensuring compliance with regulatory standards. In this role, you’ll collaborate across departments to analyze post-market data, conduct root cause investigations, and develop solutions that enhance product performance and customer satisfaction. If you’re a detail-oriented problem solver with expertise in design verification, validation, and regulatory compliance, we encourage you to apply and make an impact on healthcare innovation.

    Knowledge:

    + Expertise in FDA Quality Systems Regulation (QSR), Design Control requirements, ISO 13485, ISO 14971 (Risk Management), and Medical Devices Directive.

    + Strong understanding of manufacturing processes, including machining, injection molding, common joining methods, and rapid prototyping.

    + Knowledge of tolerance stack-ups, Design for Manufacturability (DFM), and Geometric Dimensioning & Tolerancing (GD&T).

    + Familiarity with Good Laboratory Practices and risk management tools throughout the product lifecycle.

    Skills:

    + Proven ability to lead design changes, product enhancements, and quality projects, ensuring compliance with design verification and validation requirements.

    + Strong knowledge of root cause failure analysis, statistical methods, and design of experiments (DOE).

    + Competency in statistical analysis tools, such as MiniTab, for data-driven decision-making.

    + Proficiency with CAD tools (e.g., SolidWorks) to design fixtures and prototypes supporting validation activities.

    + Technical writing skills for authoring protocols, reports, requirements, and risk documentation.

    + Ability to develop test methods, protocols, and reports for design verification, validation, and process validation activities.

    + Collaborative team player with strong communication skills to work effectively across R&D, Quality, and Regulatory teams.

    Behaviors:

    + Action-oriented and detail-focused, ensuring timely and accurate execution of tasks and deliverables.

    + Proactive problem solver with the ability to assess product and process risks and propose innovative solutions.

    + Customer-focused, committed to resolving quality issues and enhancing customer experiences.

    + Continuous improvement mindset, driving process optimization and identifying opportunities for technical learning.

    + Adaptable and resilient, thriving in a fast-paced, regulated environment while maintaining compliance with global standards.

    Experience:

    + Bachelor’s degree in engineering, scientific discipline, or a related field (e.g., BSME, BSEE).

    + **At least 2 years** of experience in a medical device process and/or product development environment.

    + Hands-on experience with design verification/validation, risk management, and complaint investigations.

    + Proven track record in developing solutions to design and process challenges using engineering principles and empirical methods.

     

    Why join Hologic?

     

    We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

     

    The annualized base salary range for this role is $76,800-$120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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._

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