Technical Writer chez SMC Ltd.

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Job Summary: Responsible to create, edit, and maintain comprehensive technical documentation for automated assembly systems for medical and pharmaceutical devices. This role focuses on translating complex engineering, software, and regulatory concepts into clear, user-friendly materials that comply with industry standards such as GAMP5, ISO 13485, FDA 21 CFR Part 820, and EU MDR. You will collaborate with cross-functional teams—including engineers, quality, manufacturing, automation, and regulatory experts—to ensure accurate communication of automation processes, from design specifications through user requirements to factory acceptance testing that will be translated to operational instructions.

Essential Job Duties and Responsibilities:

• Author technical reports, validation protocols, and automation design and development documentation per GAMP 5 requirements for automated manufacturing equipment, ensuring compliance with AAMI/ISO standards and FDA guidelines; including standard operating procedures (SOPs), work instructions, equipment manuals, and process flow diagrams for manufacturing and automation systems. 
• Collaborate with subject matter experts (SMEs) in automation engineering, manufacturing, and quality to gather and synthesize technical information to develop training materials and quick-reference guides for production technicians and operations, ensuring clarity for diverse audiences, including non-technical operators.
• Review and edit content for technical accuracy, consistency, and adherence to style guides, incorporating visuals like schematics and CAD drawings.
• Perform gap analyses on existing documentation, update legacy materials for new or updated automation features and processes.  
• Conduct research on industry trends in medical device automation, such as AI-driven diagnostics or robotic assembly lines, to support marketing collateral and white papers. 
• Support quality audits by preparing documentation for internal reviews and external inspections, ensuring all materials are audit-ready and traceable.
• Solicits feedback from internal and external customers; Develops and implements improvements.
• Performs other duties as assigned.  

Essential Qualifications:

• Bachelor’s degree in Technical Communication, English, Mechanical Engineering, Industrial Engineering, or a related field; advanced degree preferred.
• Minimum 3 years of experience in technical writing within manufacturing, industrial engineering, or automation industries.
• Proficiency in documentation tools like Microsoft Office Suite, Adobe FrameMaker, Visio for diagrams, and version control systems (e.g., Git or SharePoint).
• Familiarity with manufacturing processes, such as machining, assembly, or robotic automation, and related technologies (e.g., PLC programming, SCADA, or ERP systems).
• Basic understanding of CAD software (e.g., AutoCAD, SolidWorks) to interpret technical drawings for documentation.
• Experience with regulatory and quality documentation, including SOPs, process validation, or compliance with ISO 13485 standards.
• Demonstrated effective verbal and written communication skills.
• Excellent organizational skills and attention to detail. 
• Excellent time management skills with a proven ability to meet deadlines. 

Desirable Qualifications:

• Certification in technical writing (e.g., STC Certified Professional Technical Communicator) or lean manufacturing/Six Sigma.
• Strong understanding of medical or pharmaceutical device manufacturing, GMP (Good Manufacturing Practices), and risk management standards (e.g., ISO 14971).

ADA Requirements:

• Typically sits, grasps items and performs keyboarding for frequent operation of a computer
• Stand, walk, bend, reach or otherwise move about occasionally
• Lift, move or otherwise transfer items up to 50 lbs. occasionally
• Exposure to typical machine shop physical hazards which may require respiratory protection

 What SMC has to offer?

• Clean, Climate-Controlled Environment
• Stable schedule 
• Paid holiday and PTO
• Health, dental, and vision insurance
• 401(k) retirement savings
• Life and disability insurance
• Promotional opportunities
• Training and career growth programs
• Amazing co-workers
• Tuition reimbursement
• Employee Assistance Program

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.  If your experience is close to what you see listed here, please still consider applying.  We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.  Please let us know if you require reasonable accommodations during the interview process. 

 

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

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