Quality Engineer

Innovation starts from the heart. At client, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As part of our Quality Engineering team, you will work closely with our R&D and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

• Perform Quality Engineering activities related to product development and ongoing cleanroom build support
• Ensure NPD processes comply to quality system and applicable regulatory standards.
• Update risk management and design control files. Maintain relevant quality documentation.
• Develop and execute test methods validations and qualification plans.
• Support design verification and facilitate process validation and commercialization activities related to multi-site transfer.
• Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing.
• Other duties assigned by Leadership.

• Bachelor’s degree in engineering or Scientific field & 4+ years' experience
  -OR
  - Master's Degree or equivalent in Engineering or Scientific field & 3+ years' experience

• Technical Documentation
• Design FMEA

• Proficient understanding of medical device operations and/or manufacturing processes. Medical Device experience strongly preferred.
• Relevant experience in product development, quality assurance, and/or related fields
• Knowledge and understanding of Engineering and Quality principles, theories, and concepts
• Understanding of ISO 13485
• Experience developing, updating, and maintaining technical content of risk management files
• Basic understanding of statistical techniques. Experience using statistical software (i.e. Minitab) a plus.
• Experience in test method development including validation and/or fixture development
• Solid problem-solving, organizational, analytical, and critical thinking skills
• Good documentation and communication (e.g., written and verbal) skills with keen attention to detail
• Ability to build productive working relationships and interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment