Job Description:
Pay Range: $54.18hr - $59.18hr
Responsibilities
* 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.
Required
* 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.
Preferred
* 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.
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