Biolinq · 1 day ago
Senior Quality Engineer
San Diego,CA,US
Full-time
Onsite
Mid, Senior Level
$85K/yr - $110K/yr
5+ years expBiolinq 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. The Senior Quality Engineer is responsible for leading Quality Engineering activities, focusing on design controls and product risk management, while ensuring product safety, performance, and regulatory compliance.
BiotechnologyHealth CareMedical DeviceWearables
Responsibilities
Partner closely with R&D and engineering teams to ensure design control activities are properly executed and documented, including development and review of design inputs, outputs, verification and validation strategies, and design changes
Support development of specifications, test methods, and acceptance criteria to verify and validate design choices using appropriate statistical methods
Lead and support product risk management activities, including hazard analyses, DFMEA, PFMEA, and linkage of risk controls to design and process requirements
Lead Quality evaluation of clinical device observations and product complaints, including determination of investigation requirements, assessment of risk and design impact, and ensuring appropriate escalation (e.g. risk file updates, design changes, CAPAs)
Support manufacturing quality activities, including review of Build Requests, risk-based review of Device History Records (DHRs), and execution of manufacturing line audits to verify compliance with approved procedures and specifications
Support supplier quality activities, including supplier evaluation, qualification, and monitoring, review of supplier nonconformances and investigations, and participating in supplier audits, as needed
Support maintenance and continuous improvement of the Quality Management System (QMS), including updating SOPs and presenting key Quality metrics as part of Management review
Support internal and external audits, serving as a key Quality representative during regulatory inspections and notified body audits
Qualification
Required
BS Degree or higher in Mechanical, Electrical, Chemical, Biomedical Engineering or related technical discipline
5+ years experience in a regulated medical device development environment (i.e. 510(k), PMA)
Demonstrated working knowledge of medical device quality systems and regulations, including design controls (21 CFR 820.30), ISO 13485, and associated practices such as Risk Management (ISO 14971) and Design History Files (DHF)
Proven ability to apply statistical and data-driven methods to support design verification, validation, and quality decision-making, including understanding of sample size rationale, variability, confidence, and acceptance criteria
Experience using statistical and analytical tools (e.g., Excel, JMP, Minitab, R)
Highly proficient with Windows-based business applications, including effective use of Excel for data analysis and Word/PowerPoint for preparation of technical and quality documentation
Strong organizational and communication skills, with the ability to manage multiple priorities, exercise sound judgment, and clearly communicate complex concepts
Highly methodical, detail-oriented, and comfortable operating in a fast-paced, evolving development environment
Benefits
Medical
Dental
Vision
Health savings account
Flexible spending account
Life and long-term disability insurance
401(k) plan
Holidays
PTO
Company
Biolinq
Biolinq develops a wearable biosensor platform that is capable of measuring blood level information.
51-200 employees
H1B Sponsorship
Biolinq has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$276.3MKey Investors
Alpha Wave VenturesRiverVestAphelion Capital,JDRF T1D Fund,LifeSci Venture Partners
2025-03-19Series C· $100M
2024-04-04Series Unknown· $58M
2021-11-02Series B· $100M
Leadership Team
Rich Yang
CEO
Jared Tangney
Co-Founder, President & CTO
Recent News
Medical Device Network
2026-02-02
2025-12-24
Company data provided by crunchbase