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Senior R&D Engineer

2 months ago

Brea, California, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Senior R&D Engineer

We are seeking a highly skilled Senior R&D Engineer to join our team at Katalyst Healthcares and Life Sciences. As a key member of our R&D team, you will be responsible for driving commercialization of new products and design changes for current products through development, qualification, and launch phases.

Key Responsibilities:
  • Develop and execute strategy for qualification of medical devices, including design verification, design validation, and design transfer activities.
  • Contribute to building organizational effectiveness through creating, leveraging, and sharing best practices, seeking and providing training, and driving technical and workflow innovation.
  • Lead cross-functional teams to develop and implement design controls, ensuring compliance with regulatory standards.
  • Collaborate with stakeholders to identify and mitigate risks, and develop strategies to build functional capability.
  • Develop and maintain technical documentation, including protocols, reports, and work instructions.
Requirements:
  • Bachelor's degree in mechanical or biomedical engineering, or advanced degree in a related field.
  • 6+ years of experience in medical device or regulated industry, or equivalent experience in a related field.
  • Proven track record of technical problem-solving and effective product development.
  • Design controls expertise and experience with regulatory standards, including FDA QSR 21 CFR 820, ISO 13845, ISO14971, and ISO 80369.