Medical Device Manufacturing Documentation Specialist

SetPoint Medical; California (MO); On-site; USD 85,000 - 115,000; Full time

Job summary

SetPoint Medical is seeking an experienced Technical Writer to support Manufacturing Engineering and Operations by developing, maintaining, and improving manufacturing documentation for our commercial medical device products. The writer will collaborate with subject matter experts to ensure clear, accurate, and compliant documentation used in production and operations.

Responsibilities include producing work instructions, procedures, forms, and training materials, and coordinating reviews to

Qualifications

• 4+ years of technical writing in regulated industries.
• Experience developing manufacturing work instructions and procedures.
• Understanding of document control in a regulated environment.
• Knowledge of GMP, GDP, and quality systems such as ISO 13485.

Responsibilities

• Research, gather, and translate technical information into clear documentation.
• Develop and maintain work instructions, procedures, forms, and training materials.
• Coordinate document reviews, approvals, and changes with cross-functional teams.
• Ensure documentation is accurate, compliant, and properly formatted.

Skills

Technical writing

Document control

ISO 13485 knowledge

MS Word

Clear communication

Cross-functional collaboration

Education

Bachelor's degree in Technical Writing or related field

Equivalent combination of education and experience

Tools

Visio

Adobe Acrobat Pro

Electronic document management systems

Job description

SetPoint Medical is seeking an experienced Technical Writer to support Manufacturing Engineering and Operations by developing, maintaining, and improving manufacturing documentation for our commercial medical device products. The writer will collaborate with subject matter experts to ensure clear, accurate, and compliant documentation used in production and operations.

Responsibilities include producing work instructions, procedures, forms, and training materials, and coordinating reviews to