Medical Device Documentation Specialist

1 month ago


San Jose, California, United States Sterling Engineering Inc. Full time
Job Title: Medical Device Documentation Specialist

At Sterling Engineering Inc., we are seeking a highly skilled Medical Device Documentation Specialist to join our team. As a key member of our Research and Development department, you will be responsible for creating and managing technical documentation for our medical device products.

Key Responsibilities:
  • Develop and maintain technical documentation that meets organizational standards, including standard operating procedures, design specifications, study protocols, and user manuals.
  • Coordinate change requests within the change management process for R&D, including updates to specifications, labeling, and SOPs.
  • Review and audit technical publications deliverables to ensure quality and consistency.
  • Execute the creation and refinement of documentation in response to regulatory changes and quality system updates.
  • Collaborate with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent.
  • Manage the review and approval process for all technical documentation to ensure compliance with regulatory requirements.
  • Ensure documentation is up-to-date, accurate, and accessible to all stakeholders.
Requirements:
  • Bachelor's Degree or Master's in Engineering, Science, or a related field.
  • 3+ years of experience in technical writing for medical device development, including complex systems and hardware, software, and reagents.
  • Experience working in a regulated industry, such as FDA or ISO.
  • Proficient in documentation tools, including Office, Adobe Acrobat, and content management systems.
  • Excellent written and verbal communication skills, with the ability to effectively communicate technical information to various audiences.
  • Ability to work collaboratively in a cross-functional team environment and prioritize multiple projects simultaneously.

We are an equal opportunity employer and welcome applications from qualified candidates without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.



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