Director, Technical Operations
About The Position
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. The Director of Technical Operations will lead and scale Biolinq’s Technical Operations team, ensuring seamless integration of engineering, manufacturing, and quality systems to support ongoing product manufacturing. This role is critical for monitoring, controlling, troubleshooting, and continually improving the quality of ongoing product manufacturing. The leader and team will ensure operational excellence by implementing, monitoring, and maintaining robust and well-characterized manufacturing processes while fostering cross-functional collaboration between R&D, Manufacturing Operations, supply chain, Quality and Regulatory teams.
Requirements
- Advanced degree (MS, MBA, PhD) in a technical or business discipline.
- 2+ years of progressive experience in technical operations within medical device, biotech, or related industries.
- Adept at root-cause analysis and implementing robust corrective actions in a technical environment.
- Demonstrated ability to Inspire teams and build alignment across departments without direct authority.
- Proven track record of transferring products and processes from development into ongoing manufacturing.
- Deep knowledge of manufacturing processes, quality systems, and regulatory compliance.
- Strong leadership, communication, and problem-solving skills.
- Ability to thrive in a fast-paced, startup environment.
- Willingness and ability to work on site.
Nice To Haves
- Experience with biosensors or wearable technology.
- Familiarity with high-volume manufacturing and automation.
Responsibilities
- Help define and execute the technical operations strategy aligned within Biolinq’s business objectives
- Build and mentor a high-performing team
- Establish and optimize processes for product transfer from development to manufacturing.
- Drive continuous improvement initiatives to enhance product performance, yield, reliability, and scalability.
- Partner closely with R&D and Product Development teams to ensure design for manufacturability (DFM) and seamless transfer of new products to production (NPI).
- Own test method development and delivering to manufacturing contracted yield, quality, and throughput.
- Serve as a key liaison for technical operations during audits and regulatory submissions.
- Implement robust risk assessment and mitigation strategies for production and supply continuity.
- Ensure adherence to ISO 13485, FDA, and other applicable regulatory requirements.
- Develop and manage departmental budgets, resource allocation, and vendor relationships.
Benefits
- Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
51-100 employees
