Senior Medical Device Software Design Assurance Engineer

Hologic, Inc.; Newark (DE); On-site; USD 97,600 - 152,700; Full time

Job summary

Hologic, Inc. seeks a Senior Software Design Assurance Engineer in Newark, DE, responsible for quality and regulatory compliance of medical device software. This role requires strong knowledge of regulations and the software development lifecycle, emphasizing risk management and collaboration.

Ideal candidates will have 5+ years of relevant experience and a Bachelor's degree in a related field. The position includes a competitive salary range of $97,600-$152,700, depending on experience and qualifications.

Qualifications

• 5+ years of medical device industry experience or 3+ years with a Master’s degree.
• Proven track record in applying medical device regulations to software projects.
• Experience in leading design assurance activities through product lifecycle.

Responsibilities

• Ensure quality, safety, and regulatory compliance of medical device software.
• Establish software design controls and verification/validation processes.
• Collaborate with engineering teams to deliver compliant software solutions.

Skills

Agile/iterative design controls

Software verification and validation (V&V)

Statistical software (e.g., Minitab)

Software security skills

Excellent communication

Education

Bachelor’s degree in Computer Science/Engineering

Job description

Hologic, Inc. seeks a Senior Software Design Assurance Engineer in Newark, DE, responsible for quality and regulatory compliance of medical device software. This role requires strong knowledge of regulations and the software development lifecycle, emphasizing risk management and collaboration.

Ideal candidates will have 5+ years of relevant experience and a Bachelor's degree in a related field. The position includes a competitive salary range of $97,600-$152,700, depending on experience and qualifications.