Medical Device Manufacturing Technical Writer

SetPoint Medical; California; Hybrid; USD 70,000 - 100,000; Full time

Job summary

SetPoint Medical in Valencia, CA, is seeking an experienced Technical Writer to support Manufacturing Engineering and Operations by creating, maintaining, and improving manufacturing documentation for our 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.

Qualifications

• Bachelor's degree in Technical Writing or related field preferred.
• 4+ years of technical writing experience in a regulated industry (medical device, pharma, biotech) or equivalent.
• Experience developing manufacturing work instructions, procedures, specifications, or other controlled docs.
• Understanding of document control in a regulated manufacturing environment.
• Knowledge of GMP, GDP, and ISO 13485 requirements.

Responsibilities

• Research, develop, write, edit, and maintain manufacturing documentation.
• Independently gather technical information from SMEs and translate complex processes into clear docs.
• Develop and maintain work instructions, procedures, process specs, forms, and training materials.
• Support documentation related to equipment, assembly, inspection, changes, validations, and transfers.
• Coordinate document reviews and approvals with cross-functional stakeholders.
• Identify opportunities to improve clarity, usability, and efficiency of docs.
• Support operator training and rollout of revised docs.

Skills

Technical writing

Regulatory awareness

ISO 13485

GMP/GDP

Document control

MS Office

Adobe Acrobat Pro

Cross-functional collaboration

Education

Bachelor's degree in Technical Writing or related field

Tools

Microsoft Word

Excel

Visio

Adobe Acrobat Pro

EDMS / Document Management System

Job description

SetPoint Medical in Valencia, CA, is seeking an experienced Technical Writer to support Manufacturing Engineering and Operations by creating, maintaining, and improving manufacturing documentation for our 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.