Senior Medical Device Manufacturing Engineer

Biolinq, Inc.; San Diego (CA); Vor Ort; USD 110.000 - 125.000; Vollzeit

Benefits dieser Stelle

Medical

Dental

Vision

401(k)

HSA/ FSA

Paid time off

Zusammenfassung

Biolinq, Inc. is seeking an engineering-focused manufacturing specialist to drive quality and efficiency in a high-volume production environment.

You will lead process monitoring, DOE activities, and line qualification with cross-functional teams to ensure robust, compliant manufacturing for our intradermal biosensor platform. The role emphasizes problem solving, data-driven decision making, and collaboration with R&D, quality, and supply chain to scale production while maintaining safety and

Qualifikationen

• BS degree in Mechanical/ Bioengineering/ Chemical/ Manufacturing or scientific discipline.
• 5–8 years related experience; MS/PhD preferred.
• Experience with DOE and statistical tools (ANOVA, t-test).
• Root-cause investigation tools (Ishikawa, A3, 5Y).
• Experience in high-volume manufacturing in medical device/electronics/biotech.

Aufgaben

• Support production monitoring with in-process test execution and trending.
• Define alert limits based on process performance.
• Maintain test methods and documentation; ensure ergonomics and safety.
• Collaborate with vendors to design tooling for fixtures.
• Lead line replication and re-qualification for demand and suppliers.
• Maintain risk documentation (PFMEA) and CAPA actions.
• Coordinate with Planning for build schedule and material needs.
• Provide training on engineering and V&V builds to operators.
• Develop sustaining cost models for labs and parts.
• Monitor production status and drive continuous improvement.

Kenntnisse

Lean manufacturing

Six Sigma

Root cause analysis

Statistical tools

Project management

Documentation

Ausbildung

BS degree in engineering or science

MS or PhD preferred

Tools

JMP

Minitab

ERP

MES

MS Project

Visio

SolidWorks

Jobbeschreibung

Biolinq, Inc. is seeking an engineering-focused manufacturing specialist to drive quality and efficiency in a high-volume production environment.

You will lead process monitoring, DOE activities, and line qualification with cross-functional teams to ensure robust, compliant manufacturing for our intradermal biosensor platform. The role emphasizes problem solving, data-driven decision making, and collaboration with R&D, quality, and supply chain to scale production while maintaining safety and