Manufacturing Technical Writer – Medical Devices

SetPoint Medical; Santa Clarita (CA); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

SetPoint Medical is seeking a Technical Writer to support the Manufacturing Engineering and Operations organization. You will develop, maintain, and improve manufacturing documentation for commercial medical device products, translating intricate processes into clear instructions and ensuring compliance with GMP and GDP standards.

You will work with manufacturing engineers, operations, quality, product development, and supply chain teams to produce work instructions, procedures, and training

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.

Responsabilités

• Research, develop, write, edit, and maintain manufacturing documentation in collaboration with Manufacturing Engineering, Operations, Quality, Product Development, and other stakeholders.
• Independently gather technical information from subject matter experts and translate complex manufacturing processes into clear, user-friendly documentation.
• Develop and maintain work instructions, procedures, process specifications, forms, training materials, and related production documentation.
• Support documentation for manufacturing equipment, assembly processes, inspection activities, process changes, validations, and manufacturing transfers.
• Observe processes with Manufacturing Engineering and production personnel to ensure written instructions reflect activities.

Formation

Associate's or Bachelor's degree in Technical Writing, Communications, Engineering Technology, Life Sciences, or a related field

Outils

Microsoft Word

Excel

PowerPoint

Visio

Adobe Acrobat Pro

Electronic document management systems

Description du poste

SetPoint Medical is seeking a Technical Writer to support the Manufacturing Engineering and Operations organization. You will develop, maintain, and improve manufacturing documentation for commercial medical device products, translating intricate processes into clear instructions and ensuring compliance with GMP and GDP standards.

You will work with manufacturing engineers, operations, quality, product development, and supply chain teams to produce work instructions, procedures, and training