Technical Writer (Contract)
Key Skills for This Role
Full Job Posting
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 Travel
- This 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 Engineering
FLSA Status: Hourly, Non-Exempt
Location
- Valencia, CA
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Candidates must have and maintain authorization to work within the United States as a condition of employment.
- We are proud to be an equal opportunity employer and we value diversity. SetPoint does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
- Salary Description
- $40-$50/hour, depending on experience
About SetPoint Medical
Commercial-stage medical technology company developing implantable neurostimulation therapy for adults with rheumatoid arthritis and other autoimmune diseases.
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