Job Description

Softwares:

• Windchill (document control).
• A plus – Solidworks, Minitab, Keyence

Nice to haves:

• Product development Experience in surgical valve related fields
• Risk documentation development/maintenance
• Understanding of statistical process

Must Haves:

• Engineering or related fields,
• Experience in regulated industry (e.g. ISO 13485/5840) or with quality stds (eg. ISO)
• Analytical and detail-oriented

How you will make an impact:

• Perform Quality Engineering activities related to product development and existing product support
• Ensure NPD processes comply to quality system and applicable regulatory standards.
• Conduct DHF gap assessment to identify and assess risks. Develop and implement effective mitigation strategies to address risks.
• Remediate risk management and design control files. Maintain relevant quality documentation.
• Develop and execute test methods validations and qualification plans.
• Support design change and facilitate process transfer from development to production.
• Assist with non-conformance resolution.
• Analyze complaints and conduct Benefit-Risk assessment.
• Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing.
• Other duties assigned by Leadership.

What you'll need (Required):

• Bachelor’s degree in engineering required
• 2-4 years' experience required

What else we look for (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
• Print reading skills
• Understanding of statistical techniques. Experience using statistical software (Minitab, JMP) a plus. CAD experience (Solidworks -or- Creo) a plus
• Experience in test method development including validation and/or fixture development
• Understanding of medical device operations and/or manufacturing processes
• Solid problem-solving, organizational, analytical and critical thinking skills
• Good documentation, communication (e.g., written and verbal) skills
• 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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