Staff Process Engineer

2 days ago


San Diego, California, United States Kaygen, Inc. Full time
Job Title: Staff Process Engineer

Job Summary:

We are seeking a highly skilled Staff Process Engineer to join our team at Kaygen, Inc. The ideal candidate will have expertise in defining and implementing software design and development processes and design control deliverables that adhere to regulatory standards within the medical device industry.

Key Responsibilities:
  • Software Process Definition: Develop and implement software processes that comply with industry standards and regulations, with a focus on the complete software development lifecycle.
  • Software Design Documentation Remediation: Develop or modify and implement software design documentation templates within the Quality Management System that comply with industry standards and regulations.
  • Leadership: Translate business and regulatory requirements into comprehensive software development processes.
  • Cross-Functional Collaboration: Facilitate effective knowledge sharing and collaboration across departments to resolve alignment or feasibility issues.
  • Continuous Improvement: Identify and drive opportunities for process improvement within the Software Engineering function to enhance efficiency, quality, clarity, and compliance.
Requirements:
  • Education: Bachelor's degree in Science or Engineering required; postgraduate degree preferred.
  • Experience: Minimum of 5 years of related work experience in software engineering, medical device development, or similar fields; experience with regulatory standards in a regulated industry highly preferred.
  • Leadership: Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader within the organization.
Technical Skills:
  • Software Engineering: Strong background in software engineering and test, and requirements management.
  • Methodologies: Experience with methodologies like DFSS or statistical test design and analysis preferred.
  • Quality Engineering: Experience in Quality engineering and design control management a plus.
Communication:
  • Exceptional Communication Skills: Strong writing abilities and attention to detail essential.

About Kaygen, Inc.: We are a leading company in the medical device industry, committed to delivering innovative solutions that improve patient outcomes. Our team is passionate about creating a culture of excellence, and we are seeking a talented Staff Process Engineer to join our team.



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