Quality Engineer II

Scientific Recruiter at Clin Lab Solutions Group What You’ll Do

• Support new product development through the full design control lifecycle
  , including design reviews, verification, validation, and design transfer across software, hardware, systems, and catheter engineering
• Partner with cross‑functional teams to ensure products meet quality, regulatory, and performance requirements
• Support sustaining engineering activities
  , including material control, inspection/acceptance, nonconforming material, equipment qualification, supplier quality, and CAPA
• Participate in risk management activities
  , including risk analysis and documentation throughout the product lifecycle
• Support software quality activities
  , including risk analysis, qualification, version releases, and documentation (IEC 62304 exposure a plus)
• Inspect and test materials, processes, equipment, and products to ensure quality specifications are met
• Support test method development and qualification
• Help design and maintain quality system processes in compliance with applicable regulations and standards
• Contribute to a culture of continuous improvement, collaboration, and patient‑first thinking

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering
  , or a related field
• 5+ years of experience in Quality Engineering or a related role within a regulated industry (medical devices strongly preferred)
• Experience supporting design controls, risk management, and validation activities
• Exposure to catheter‑based, cardiac, or complex electromechanical medical devices is highly desirable
• Working knowledge of:
  21 CFR 820
  , ISO 13485
  , ISO 14971
  , IEC 60601 and/or IEC 62304
  , HIPAA and GDPR concepts a plus
• Strong documentation skills, attention to detail, and ability to work cross‑functionally in a dynamic environment

• Work on cutting‑edge cardiac technology that directly impacts patient outcomes
• High‑visibility role supporting innovative product development
• Collaborative, mission‑driven culture with strong engineering depth
• Opportunity to grow within a complex software + hardware medical device environment

• Mid‑Senior level

• Full‑time

• Engineering, Quality Assurance, and Design

• Medical Equipment Manufacturing and Manufacturing

• Medical insurance
• Vision insurance
• 401(k)