Test Engineer II

Full-time

Description

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 Biolinqs 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 Biolinqs 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

Requirements

Qualifications

• Bachelors 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.

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 $105000 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-$105k per year