We are currently seeking a Software Verification and Validation Engineer who will be responsible for testing software for highly complex medical devices/instrumentation for IVD Product Development and IVD Product Testing.
*The schedule for the position is Tuesday-Saturday, or Wednesady-Sunday, hours will be 2 PM - 11 PM.
Duties & Responsibilities:
- Design and development of test protocols for new and advanced features.
- Apply experience with black box testing to plan, write test cases, test reports, and test software and hardware requirements for a Class II Medical Device.
- Write technical test protocols and technical reports.
- Perform Verification and Validation testing in an FDA/UL regulated environment.
- Assist with all aspects of medical device life cycle process, IEC 62304.
- Troubleshoot product problems, improvements or field complaints.
- Review data and recommend courses of action.
- Assist with root cause analysis.
- Support Regulatory Affairs for 510(k).
- Perform laboratory work to assure completion in accordance with established safety procedures and applicable regulatory regulations.
- Ensure software validation procedures and guidelines are maintained and kept current with FDA guidelines.
- Work with molecular diagnostic technology and nucleic acid amplification.
- Develop V&V technical plans and protocols.
- Review SOPs for compliance.
- Assist with tools validation.
- Mentor junior team members in daily tasks, providing feedback as needed.
- Work hours are from 2 PM to 11 PM, Tuesday through Saturday or Wednesday through Sunday, 40 hours per week.
- Master’s degree or Bachelor’s degree in Computer Science, Systems Engineering, Biomedical Engineering, or related field.
- At least one year of software testing experience.
- Hologic will accept any suitable combination of education, training, and/or experience.
SkillsExperience with one or more of the following is preferred:
- FDA/UL software validation guidelines;
- Complex instrumentation platform;
- Evaluation methods in the design, development and debugging of SW programs;
- IVD Product Development and IVD Product Testing;
- Molecular diagnostic technology and nucleic acid amplification;
- Medical device software life cycle process, IEC 62304;
- Writing technical test protocols and technical reports; and
- Black box testing.
- Candidate must be physically capable and willing to work in a lab environment 6-7 hours/day performing system level manual testing on a complex instrumentation platform.
- Candidate will be required to work in the 2 PM shift.
- Candidate will be required to work in the Tuesday-Saturday or Wednesday-Sunday work week.
- Sit; use hands to finger, handle or feel objects, tools, or controls.
- Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
- Lifting/moving and carrying products weighing up to 40 pounds.
- Exposure to moving mechanical parts, vibration and/or moderate noise levels.
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.
Job Type: Full-time