Validation Engineer Biomedical Jobs in Delaware (NOW HIRING)

Hologic is seeking a Systems Engineer to join our Research and Development team in Newark, Delaware. In this role, you will contribute to the development of advanced medical imaging systems and electromechanical subsystems that help improve clinical outcomes. This position requires regular onsite presence in Newark, DE to collaborate closely with crossfunctional engineering teams and support handson system integration, testing, and troubleshooting.

You will work alongside electrical, mechanical, and software engineers, scientists, and product owners to support the design, integration, verification, and validation of medical imaging technologies.

Key Responsibilities

• Contribute to the specification, design, component selection, system integration, verification, and validation of medical imaging systems and electromechanical subsystems.
• Develop an indepth understanding of system architecture design and clinical use of medical imaging systems.
• Propose system definitions and specifications to meet customer requirements and user needs.
• Support concept development, specification, and design of new medical imaging products.
• Implement new electromechanical designs and modifications within defined cost, schedule, and performance targets.
• Maintain traceability between system requirements and subsystem requirements.
• Maintain traceability between product requirements, identified risks, and mitigation strategies.
• Perform handson troubleshooting at system and subsystem levels.
• Support engineering teams and system quality assurance through concept, implementation, and verification phases.
• Collaborate with design engineers to define test methods and conditions.
• Complete design documentation and Engineering Change Orders in accordance with Hologic procedures and best practices.
• Create project schedules, track progress, and report status or issues to management and project teams.
• Support design transfer to manufacturing.
• Establish collaborative relationships with stakeholders across the division.
• Manage multiple projects concurrently under supervision.
• Continue to build technical expertise and professional development, contributing to innovative problemsolving and product development.

Qualifications

Education

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a related technical discipline.

Experience

Preferred minimum:

• 1-2 years of experience with a technical bachelor's degree, or
• 0-2 years with a master's degree.

Skills and Knowledge

• Understanding of systems engineering methodologies.
• Experience with electromechanical design and embedded software development, ideally within the medical device field.
• Experience with systems integration across electrical, mechanical, and software components.
• Knowledge across multiple engineering disciplines.
• Strong critical thinking, analytical, and problemsolving skills.
• Familiarity with physical and mathematical modeling tools.
• Knowledge of medical device regulations and standards, including: FDA QSR, ISO 13485, ISO 14971, IEC 606011 and IEC 6060112, IEC 62304 (software lifecycle for medical devices)
• Experience with Product Lifecycle Management (PLM) systems.
• Strong communication, teamwork, and collaboration skills.
• Experience with technical documentation and presentations.
• Project management skills.
• SolidWorks experience is a plus

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.

The annualized base salary range for this role $78,000 - $122,100 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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