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12429
Temp-to-Perm

SW V & V Engineer

Location: San Diego, California

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Software V&V Engineer

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration – Contract
  • Pay rate:  $35-37/hr. 
  • Job Location:  San Diego, CA
  • Job# bh12429

SW V & V Engineer

  • Prefers green candidates | 1-3 years, BS in Biomedical, Bioinformatics, Chemical or Electrical Engineering would work. Some experience with R&D Systems testing is required. Does not require med device experience.
  • Requires med device.
  • All candidates must have some level of R&D experience.

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.
  • 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.
  • Assist with root cause analysis.
  • 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.
  • Assist with tools validation.

Experience

  • At least one year of software testing experience.
  • Will accept any suitable combination of education, training, and/or experience.

Skills

  • Experience with one or more of the following is preferred:

1. FDA/UL software validation guidelines;

2. Complex instrumentation platform;

3. Evaluation methods in the design, development and debugging of SW programs;

4. IVD Product Development and IVD Product Testing;

5. Molecular diagnostic technology and nucleic acid amplification;

6. Medical device software life cycle process, IEC 62304;

7. Writing technical test protocols and technical reports; and

8. 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 2 PM -11pm shift based on project needs.

Candidate will be required to work in either the Saturday-Wednesday or Tuesday -Saturday work week based on project needs.

 

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

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