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Software Quality Engineer II

4 months ago

Lafayette, United States Primary Talent Partners Full time
Primary Talent Partners has a 6 month contract opening for a Software Quality Engineer II to join a multinational medical device company for an onsite position in Lafayette, CO.

Assignment Type: You will be sitting on a W2 with Primary Talent Partners - We cannot provide sponsorship or accept C2C candidates for this assignment.

Pay: $55.00/hr - $60.00/hr

Responsibilities:
  • This position has the opportunities to work with more senior software quality engineers to support all software lifecycle related activities:
  • New Product Development lifecycle, such as the design, development, test, and market release of Product software used in real time Navigation System in our Neuroscience team;
  • Post Market Release lifecycle, such as remediation, CAPA, and other activities as assigned.
Responsibilities may include but not limited to the following activities, with mentor/coach/guidance from more senior Software quality engineers:
  • Supports product quality ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices.
  • Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
  • Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
  • Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.
Required Qualifications:
  • Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
Nice to Have
  • Experience in the medical device industry
  • Experience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
  • Navigation systems experience preferred
  • Excellent oral and written communication skills

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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