Test Engineer II

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 motivated and collaborative Test Engineer II with experience in design verification and/or validation, including human factors and usability testing. This individual will play a key role in testing Biolinq’s current and next-generation systems by developing requirements, conducting risk analyses, creating innovative test methods and systems, and executing verification and validation tests to support clinical studies and regulatory submissions.

The role includes planning and conducting bench experiments or usability studies, analyzing data, and working cross-functionally to deliver reliable, user-friendly products. This position is based at Biolinq’s corporate headquarters in San Diego, CA.

Duties and Responsibilities Cross-Functional Collaboration

Partner with mechanical, electrical, firmware, software, chemistry, and process teams to evaluate designs and technologies. Align efforts with PMO, Regulatory, and Product teams to support product/project strategies. Support integration of subsystems into a cohesive, high-performing system. Assess design and process changes for impact on system and sensor performance. Ensure product requirements are measurable, testable, and aligned with stakeholder goals.

Feasibility Testing, Characterization and Analysis

• Design and execute hypothesis-driven experiments for feasibility, root cause analysis, and process optimization.
• Design and develop test fixtures and/or equipment to evaluate system and subsystem performance.
• Track technology maturity and alignment with product requirements.
• Analyze data using statistical methods and design of experiments (DOEs) to generate conclusions or insights.
• Provide actionable feedback to design and process owners.
• Document and track design issues, risks, and system interdependencies.

Design Verification and Compliance

• Define and manage design requirements throughout the development lifecycle.
• Develop and validate test methods for design verification.
• Lead or support design verification and compliance testing (e.g., IEC 60601, EMC, wireless coexistence).

Human Factors Usability and Design Validation

• Create usability plans, use specifications, and risk analyses.
• Conduct formative usability studies to inform design decisions.
• Plan and execute design validation activities.

Documentation and Reporting

• Author protocols, reports, and technical documentation.
• Develop procedures based on experimental findings.
• Present findings and updates to stakeholders and leadership team.

General Responsibilities

Adapt to evolving business needs and take on additional responsibilities as required.

Qualifications

• Bachelor’s degree or higher in Mechanical, Electrical, Biomedical Engineering, or a related field.
• 2+ years of experience in engineering and product development.
• Experience with test method development, design verification and systems integration.
• Strong analytical skills with a detail-oriented, methodical approach to problem-solving.
• Proficiency in data analysis, statistical methods and tools (e.g., Excel, JMP, MATLAB, R).
• Familiarity with CAD (e.g., Solidworks) and fixture design.
• Familiarity or strong interest in usability and human factors engineering.
• Self-motivated and capable of managing multiple projects at once.
• Capable of working both independently and cross-functionally with minimal supervision.
• Excellent communication skills, including technical documentation and stakeholder presentations.
• Effective collaborator across multidisciplinary teams in a fast-paced environment.
• Professional presence and interpersonal skills to build strong working relationships.
• Familiarity with regulatory standards (e.g., IEC 60601-1, IEC 62336-1, ISO 14971, FDA) is a plus.

Working Conditions

• Primarily based on-site, in an office and laboratory environment.
• Up to 70% of time may be spent in a laboratory or cleanroom setting.
• 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.

Equal Employment Opportunity Statement

At Biolinq we fully…