Senior Systems Engineer

Are you passionate about developing cutting-edge medical devices and solving complex technical challenges? At Hologic we’re looking for a Senior Systems Engineer to drive product sustainment, improve design history compliance, and collaborate across disciplines to enhance clinical outcomes and patient care. We are open to our Newark, DE or Marlborough, MA locations with a hybrid schedule. Apply today ! 
 

To excel in this role, you’ll need expertise in:

• Medical Device Compliance: Proficiency in FDA QSR (21 CFR Part 820), ISO 13485, and design controls.
• Systems Engineering: Knowledge of methodologies, physical and mathematical modeling tools, and complex system integration.
• Product Development: Understanding of hardware, software, and mechanical components in regulated environments.
• Design History Files (DHF): Experience with DHF remediation and adherence to regulatory standards.
• Risk Management: Familiarity with risk assessment frameworks (e.g., ISO 14971) and CAPA processes.
• Medical Technologies: Knowledge of medical imaging systems, devices, and clinical workflows.

We’re looking for someone who excels in:

• Problem-Solving: Critical thinking and analytical skills to tackle complex technical challenges.
• Communication: Strong written and verbal skills for engaging with technical and non-technical stakeholders.
• Technical Leadership: Ability to lead subsystem architectural discussions, verification and validation testing, and troubleshooting.
• Collaboration: Proven experience in working cross-functionally across engineering, regulatory, and clinical teams.
• Project Management: Skilled at meeting deadlines and managing multiple projects simultaneously.
• Tools Proficiency: Familiarity with Agile methodologies, Oracle platforms, and system modeling software.

The ideal candidate will demonstrate:

• Proactive Leadership: Takes initiative to lead technical projects and ensure high-quality outcomes.
• Adaptability: Thrives in dynamic, fast-paced environments with competing priorities.
• Collaboration: Builds strong relationships across multidisciplinary teams to achieve shared goals.
• Customer Focus: Keeps the voice of the end user at the forefront of all decisions.
• Continuous Improvement: Committed to fostering a culture of learning, innovation, and product excellence.

To succeed in this role, you should have:

• 5–8 years of experience in systems engineering or related fields (or equivalent based on education level).
• A Bachelor’s degree in a technical field (Master’s or Ph.D. preferred for reduced experience requirements).
• Proven experience in developing complex medical systems involving mechanical, electrical, and software components.
• Hands-on expertise with Design History Files, requirements traceability, and system verification/validation.
• A track record of leading technical teams and delivering high-quality medical devices in regulated environments.

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 $94,000 - $146,900 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.

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