We are seeking a highly skilled Technical Writer to join our team at First Line Software, Inc. as a Design Control Specialist. In this role, you will be responsible for creating robust documentation, developing training materials, and establishing best practices for efficient and compliant product development processes.

• Design and Implement Training Content: Develop training content for internal staff on Design Control processes and documentation best practices in alignment with regulatory requirements.
• Generate Comprehensive Documentation Templates: Create documentation templates for Design Input/Output, Risk Management, Verification/Validation protocols, and other key Design Control documents.
• Collaborate with Subject Matter Experts: Work closely with subject matter experts to gather technical information and translate complex concepts into user-friendly training materials and procedural documents.
• Develop Best Practices and Examples: Develop examples and case studies illustrating best practices in Design Control documentation to streamline product development and ensure adherence to quality standards.
• Maintain a Repository of Resources: Maintain a repository of training resources, best practice examples, and document templates to support ongoing Design Control activities within the organization.
• Structure and Organize Templates: Structure and organize the templates used for project documentation.
• Standardize and Streamline Templates: Interact with quality assurance and compliance departments to standardize and streamline templates.
• Interview Stakeholders: Interview stakeholders to update and create a comprehensive template base.
• Comply with Safety Policies: Comply with all safety policies, practices, and procedures.
• Report Unsafe Activities: Report all unsafe activities to supervisor and/or Human Resources.
• Participate in Team Efforts: Participate in proactive team efforts to achieve departmental and company goals.

• Bachelor's Degree: Bachelor's degree in technical writing, engineering, or a related field.
• Proven Experience: Proven experience in developing training content and documentation for Design Control processes in the medical device industry.
• Regulatory Knowledge: Thorough understanding of regulations, ISO standards, and best practices in Design Control documentation.
• Expertise in Documentation: Expert ability to create structures and processes necessary to deliver enterprise programs/projects and/or new products to successful implementation.
• Communication Skills: Strong communication skills and the ability to collaborate effectively with cross-functional teams.
• Document Management Tools: Familiarity with document management tools, eLearning platforms, and instructional design principles.