• Lead Systems Engineer

    Hologic (Newark, DE)


    Lead Systems Engineer

     

    Newark, DE, United States

     

    Marlborough, MA, United States

     

    We are seeking two **Lead Systems Engineers** responsible for leading design, integration, and manage complex systems that meet regulatory, technical, and customer requirements in the development of our medical devices. You will play a critical role in ensuring that medical devices function as intended, meet safety and performance standards, and comply with stringent industry regulations. Apply today !

     

    Knowledge

    You bring deep expertise in:

    + Medical device development and compliance, including FDA QSR (21 CFR Part 820), ISO 13485, and design controls.

    + Engineering principles and methodologies across disciplines (e.g., mechanical, electrical, software).

    + Clinical and technical workflows, particularly in radiology and medical imaging.

    + Design History File (DHF) assessment and remediation for regulatory compliance.

    + Risk management standards (e.g., ISO 14971) and post-market surveillance processes (e.g., CAPA).

     

    Skills

    We’re looking for someone who excels in:

    + Strategic Leadership: Proven ability to lead complex, cross-functional projects and inspire teams.

    + Technical Expertise: Advanced problem-solving, critical thinking, and technical decision-making skills.

    + Communication: Exceptional storytelling, written, and verbal skills tailored to technical and non-technical audiences.

    + Collaboration: Strong interpersonal skills to build relationships across matrixed organizations.

    + Innovation: A visionary mindset with the creativity to develop and sustain cutting-edge medical technologies.

    + Tools Proficiency: Familiarity with engineering design tools, documentation systems, and quality frameworks.

     

    Behaviors

    Our ideal candidate demonstrates:

    + Proactive Leadership: Takes initiative to drive innovation and maintain product excellence.

    + Adaptability: Thrives in a dynamic, fast-paced environment while effectively managing competing priorities.

    + Collaboration: Builds trust and fosters teamwork across diverse teams and stakeholders.

    + Continuous Improvement: Committed to personal growth and fostering a culture of learning and innovation.

    + Results-Oriented: Focused on delivering measurable outcomes that align with organizational goals.

    Experience

    To succeed in this role, you should have:

    + 8+ years of experience in systems engineering or related fields, preferably in the medical device industry.

    + A Master’s degree (6+ years of experience) or Ph.D. (3+ years of experience) in a technical field.

    + Extensive hands-on experience with design, development, and sustainment of medical devices.

    + A proven track record of leading cross-functional teams and collaborating with stakeholders across disciplines.

    + Expertise in risk management, CAPA processes, and post-market surveillance.

     

    So why join Hologic?

     

    We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

     

    If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

     

    The annualized base salary range for this role is $114,800 - $179,500 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.

     

    As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

     

    Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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