Product Quality Engineer

Hologic • Newark, DE

2h

About The Position

Are you passionate about driving product quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic’s Breast and Skeletal Health Division as a Product Quality Engineer and play a pivotal role in supporting on-market devices through rigorous investigation, root cause analysis, and collaborative problem-solving.
At Hologic, our purpose is to enable healthier lives everywhere, every day. We’re looking for a Product Quality Engineer to support the quality of our on-market medical devices, helping ensure the safety and performance of products used in real clinical environments.
This is an excellent opportunity for an early-career engineer to build experience in a regulated, FDA‑controlled environment and grow within a global medical device organization.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering (required).
• 0–2 years of experience (internships/co-ops welcome).
• Experience in an FDA-regulated industry is preferred.
• Exposure to root cause analysis or product development/R&D is a plus.
• Familiarity (or strong interest in learning) FDA Quality System Regulations, ISO 13485, risk management (ISO 14971), GMP, and GDP.
• Ability to work effectively on cross-functional project teams and take ownership of critical tasks.
• Strong analytical and problem-solving skills; familiarity with root cause tools (e.g., for complaints, NCs, CAPAs) is a plus.
• Good written and verbal communication and presentation skills.

Nice To Haves

• Exposure to test method validation, failure analysis, statistics, and design of experiments.
• Familiarity with reliability, electrical safety, sterilization, packaging, or biocompatibility standards.
• Understanding of verification/validation requirements and risk-based/statistical analysis concepts.

Responsibilities

• Own complaint investigations and associated root cause analysis, coordinating with cross-functional stakeholders.
• Support risk assessments and Health Risk Assessments, helping define problem statements and evaluate impact.
• Analyze and trend complaint and failure mode data; prepare and present findings to internal stakeholders.
• Participate in implementing design or process improvements (e.g., drawings, fixtures/tooling, testing, change control).
• Help develop or improve test methods used during complaint investigations.
• Provide technical support to the complaint intake team and Post-Market Quality Assurance (PMQA) team.
• Support customer site investigations as needed to resolve field quality issues.
• Contribute to preparation of product quality metrics and participate in internal and external audits.
• Provide post-market feedback to Operations, Engineering, and R&D to improve product design and manufacturing.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level