Technical WriterSetPoint Medical is seeking an experienced Technical Writer to support the Manufacturing Engineering and Operations organization by developing, maintaining, and improving manufacturing documentation for the company's commercial medical device products. The Technical Writer will work closely with Manufacturing Engineering, Operations, Quality, Product Development, Supply Chain, and other subject matter experts to create clear, accurate, and compliant documentation supporting production and operational activities. The successful candidate must be organized, detail-oriented, self-motivated, and able to manage changing priorities in a fast-paced medical technology environment.
Requirements:
Work with Manufacturing Engineering, Operations, Quality, Product Development, and other stakeholders to research, develop, write, edit, and maintain manufacturing documentation.
Independently gather technical information from subject matter experts and translate complex manufacturing processes into clear, accurate, and user-friendly documentation.
Develop and maintain work instructions, procedures, process specifications, forms, training materials, and related production documentation.
Support documentation associated with manufacturing equipment, assembly processes, inspection activities, process changes, validations, and manufacturing transfers.
Partner with Manufacturing Engineering and production personnel to observe processes and ensure written instructions accurately reflect manufacturing activities.
Ensure manufacturing documentation is accurate, consistent, properly formatted, and compliant with document control and Quality Management System requirements.
Coordinate document reviews, revisions, approvals, and implementation with appropriate cross-functional stakeholders.
Identify opportunities to improve the clarity, usability, consistency, and efficiency of manufacturing documentation.
Support operator training and implementation of new or revised manufacturing documentation as needed.
Minimum Qualifications:
Associate's or Bachelor's degree in Technical Writing, Communications, Engineering Technology, Life Sciences, or a related field preferred; equivalent combination of education and relevant experience may be considered.4+ years of technical writing or documentation experience in medical device, pharmaceutical, biotechnology, manufacturing, or another regulated industry. Experience developing manufacturing work instructions, procedures, specifications, or other controlled technical documentation. Understanding of document control and documentation management within a regulated manufacturing environment. Working knowledge of medical device quality systems, including ISO 13485 and applicable FDA requirements. Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Adobe Acrobat Pro, and related documentation tools; experience with electronic document management systems preferred.
Skills and Abilities:
Exceptional attention to detail and document accuracy.
Excellent verbal and written communication skills.
Ability to translate complex technical processes into clear, concise instructions.
Strong organizational skills with the ability to manage multiple documentation priorities and deadlines.
Demonstrated ability to independently gather information from technical subject matter experts.
Ability to collaborate effectively with Manufacturing Engineering, Operations, Quality, Product Development, and production personnel.
Demonstrated initiative, independence, adaptability, and commitment to continuous improvement.
Physical Requirements:
Ability to sit at a desk and work on a computer for extended periods.
Ability to work periodically within manufacturing and production environments.
Ability to lift up to 15 pounds occasionally.
Work Location and TravelThis position will report to our Company Headquarters in Valencia, CA. with minimal travel opportunities based on interest and business need.
Company Description:
SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases.
Department: Operations
Reports To: Sr. Manager, Manufacturing EngineeringFLSA Status: Hourly, Non-Exempt
Location: Valencia, CA
