Hologic Jobs

Software Verification & Validation Engineer 1

San Diego, CA, United States

Job Summary

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.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• 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 in shifts from 6 AM to 3 PM OR 2 PM to 11 PM, Tuesday through Saturday, 40 hours per week.

Qualifications

Education

• Master’s or bachelor’s degrees in computer engineering, Systems Engineering, Biomedical Engineering, or related fields.

Experience

• At least one year of software testing experience.

• Hologic will accept any suitable education, training, and/or experience combination.

Skills

Experience 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.

Additional Requirements:

• 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 the 6 AM or 2 PM shift based on project needs.

• Candidates will be required to work in Tuesday -Saturday work week based on project needs.

The annualized base salary range for this role is $67,300 to $98,100 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.

Must follow all applicable FDA regulations and ISO requirements.

Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)