Senior Technical Documentation Specialist

Full-time

Description

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About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Job Purpose

Biolinq is seeking a highly organized detail-oriented and technically proficient Senior Technical Documentation Specialist to support R&D Operations Manufacturing and Quality teams throughout the product development lifecycle.

This role is responsible for developing revising coordinating and driving technical and quality system documentation while ensuring compliance with company procedures and quality requirements. The Technical Document Specialist serves as a key partner to technical teams by converting technical inputs into clear accurate and compliant documentation while leveraging AI-enabled tools and automation to improve quality consistency and execution speed.

The ideal candidate possesses strong written communication skills exceptional attention to detail and the ability to translate technical concepts for diverse stakeholders. This individual thrives in a fast-paced environment manages multiple priorities simultaneously and proactively drives documentation activities to completion.

This position is based on-site at Biolinqs headquarters in San Diego California.

Duties and Responsibilities:

Documentation Development

• Develop revise and maintain technical manufacturing and quality system documentation.
• Prepare documentation from technical discussions design reviews test data stakeholder input and other sources.
• Collaborate with subject matter experts to gather information resolve ambiguities and ensure documentation accuracy.
• Support documents such as manufacturing instructions and records test documentation technical reports change-control records quality records and risk-management documentation.

Documentation Quality and Compliance

• Ensure compliance with applicable procedures templates and quality-system requirements.
• Review documentation for accuracy completeness consistency traceability and clarity.
• Verify that documents accurately reflect approved technical content and processes.

Coordination and Execution

• Coordinate and drive documentation through review approval and release workflows.
• Track documentation status and proactively follow up with stakeholders as needed.
• Identify and resolve documentation bottlenecks and administrative obstacles.
• Partner with cross-functional teams to support timely document review approval and release.
• Manage multiple documentation activities simultaneously while maintaining quality and responsiveness.

Systems and Process Support

• Translate technical information into clear audience-appropriate documentation.
• Effectively leverage AI-enabled tools and automation to research draft review improve and streamline documentation and related business processes.
• Build effective working relationships across functions.
• Identify documentation gaps and partner with accountable owners to resolve them.

Key Success Factors

Success in this role is measured by:

• High-quality compliant documentation with minimal review findings or rework.
• Timely completion of review approval and release activities.
• Effective coordination across multiple assignments and stakeholder groups.
• Ability to independently gather information and drive activities to completion.
• Effective application of AI-enabled tools and emerging technologies to improve documentation quality consistency efficiency and stakeholder productivity.

Requirements

Qualifications

• Bachelors degree or equivalent professional experience.
• 3 years of experience in technical documentation quality systems manufacturing engineering support project coordination or a related discipline.
• Outstanding written verbal and interpersonal communication skills.
• Exceptional attention to detail and organizational skills.
• Advanced proficiency with AI-enabled productivity tools and a demonstrated ability to apply them effectively to technical documentation process improvement and workflow automation.
• Proven ability to manage multiple concurrent projects and priorities.
• Strong analytical and problem-solving abilities.
• Ability to quickly learn technical concepts and processes.
• Proficiency with Microsoft Office applications and document management systems.

Preferred:

• Experience within a medical device biotechnology pharmaceutical aerospace or other highly regulated industry.
• Experience supporting product development teams (e.g. engineering manufacturing quality regulatory etc.)
• Demonstrated ability to adopt new technologies and drive process improvements in a fast-paced product development environment.
• Familiarity with Quality Management Systems and design control requirements.
• Experience with eQMS and document control systems.
• Experience with manufacturing quality test documentation (e.g. DHRs MPIs BRs NCMRs and COs).
• Familiarity with FDA Quality System Regulation ISO 13485 and related quality frameworks.

Working Conditions

• Primarily based on-site in an office and laboratory environment
• Occasional travel (up to 10%) may be required to development activities

Physical Requirements

While performing the duties of this job the employee is regularly required to stand; walk; sit; use hands and fingers; manipulate office equipment including a personal computer; handle or feel; reach with hands and arms; climb or balance; stoop kneel crouch see talk or hear in a standard office and/or manufacturing environment. Employee may occasionally lift/or move up to 50 pounds.

BENEFITS

Medical dental vision health savings account flexible spending account life and long-term disability insurance 401(k) plan holidays and PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment compensation and other benefits related to employment based on qualifications without regard to race color religion national origin age sex veteran status genetic information disability or any other basis prohibited by federal state or local accordance with requirements of the Americans with Disabilities Act and applicable federal state and/or local laws it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal

Opportunity Employer we intend to comply fully with applicable federal state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law The Company maintains a smoke- free workplace.

As part of our efforts to ensure fair and equal pay based on merit Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $90000 to $120000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including but not limited to: skill set depth of experience education certifications and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation holidays sick time parental leave) medical/dental/vision insurance and 401(k) to eligible employees subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.

Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may at its discretion assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process please contact Biolinq Talent Acquisition at

Salary Description

$90000-$120000 annually

Required Experience:

Senior IC