We are seeking a highly skilled Technical Writer (Medical Device Experience is a must) to join our team. The ideal candidate will have experience in the medical device industry, with a strong focus on design controls, risk management, verification and validation, regulatory compliance, and labeling. This role is crucial in ensuring that all documentation related to the design and development of our orthopedic surgical robot meets the highest standards of clarity, accuracy, and regulatory compliance.

Key Responsibilities

• Documentation Development: Create, review, and maintain comprehensive documentation for the design and development of orthopedic surgical robots, including user manuals, technical specifications, design control documents, risk management reports, verification and validation protocols, and labeling documents such as Instructions for Use (IFU) and operating manuals.

• Design Controls: Collaborate with engineering, quality assurance, and regulatory teams to develop and document design control processes, ensuring compliance with FDA regulations, ISO 13485, and other relevant standards.

• Risk Management: Develop, document, and maintain risk management processes and reports in accordance with ISO 14971. Identify, assess, and document potential risks associated with the orthopedic surgical robot and propose mitigation strategies.

• Verification and Validation (V&V): Develop, document, and maintain verification and validation plans, protocols, and reports to ensure the orthopedic surgical robot meets all design and performance requirements. Work with engineering teams to ensure thorough testing and validation of the device.

• Regulatory Compliance: Ensure all technical documentation meets regulatory requirements, including CE marking, FDA submissions (510(k), PMA), and other international standards.

• Labeling: Develop and maintain accurate and compliant labeling for the orthopedic surgical robot, including IFU, operating manuals, product labels, and packaging. Ensure all labeling meets regulatory and quality standards.

• Technical Communication: Translate complex technical information into clear, concise, and user-friendly documents for various audiences, including engineers, surgeons, regulatory bodies, and end-users.

• Process Improvement: Continuously improve documentation processes and templates to enhance efficiency and compliance.

• Stakeholder Collaboration: Work closely with cross-functional teams, including R&D, QA, marketing, and regulatory affairs, to gather necessary information and ensure consistency and accuracy in documentation.

• Training and Support: Develop training materials and provide support to internal teams and end-users regarding the use and maintenance of the orthopedic surgical robot.

Qualifications

• Education: Bachelor’s degree in Technical Writing, Engineering, Life Sciences, or a related field.

• Experience: Minimum of 5 years of experience as a technical writer in the medical device industry, with a strong emphasis on design controls, risk management, verification and validation, regulatory compliance, and labeling.

• Knowledge: In-depth understanding of FDA regulations, ISO 13485, ISO 14971, and other relevant medical device standards. Familiarity with orthopedic surgical procedures and robotics is a plus.

• Skills:

o Excellent written and verbal communication skills.

o Strong attention to detail and organizational skills.

o Ability to understand and convey complex technical information.

o Proficiency in document management systems and software such as Microsoft Office, Adobe Acrobat, and other relevant tools.

o Ability to work independently and as part of a team in a fast-paced, dynamic environment.

Job Type: Contract

Pay: $45.00 per hour

Expected hours: 40 per week

Experience level:

• 4 years

Schedule:

• 8 hour shift

Work Location: On the road