Technical Writer (Contract)

SetPoint Medical; Santa Clarita (CA); In loco; USD 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Formazione

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

Strumenti

Microsoft Word

Excel

PowerPoint

Visio

Adobe Acrobat Pro

Electronic document management systems

Descrizione del lavoro

SetPoint Medical's Technical Writer will 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 & 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

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.