Senior Product Development Engineer

24 hours ago


Thousand Oaks, California, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

We are seeking a highly skilled Senior Engineer to lead our product development team in creating innovative medical devices. As a key member of our cross-functional team, you will be responsible for driving program execution, managing project schedules, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Lead medium to large projects, working closely with Program Managers to ensure successful device development.
  • Manage project schedules, identify and mitigate program risks, and drive program task execution.
  • Ensure compliance with regulatory requirements, design controls, and SOPs.
  • Collaborate with cross-functional teams to establish integrated plans for resources and materials.
  • Identify and solve complex integration problems, leading the team to deliver quality products on time and within budget.
  • Develop and execute architecture documents, design documents, and other related product development documents.
  • Provide technical assistance to junior engineers and manage project activities.
Requirements
  • Bachelor's or Master's degree in Electrical, Mechanical, Biomedical, or Computer Engineering.
  • Medical device and/or combination product development experience, including design controls.
  • Minimum 5+ years of experience in project leadership in engineering product development, manufacturing, or research environments.
  • Demonstrated ability to build lasting cross-functional relationships and strong communication skills.
  • Experience with MS Project, One Pager, MS Teams, and Smartsheet is a plus.

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