Senior Manufacturing Engineer - Medical Device Scale-Up

Biolinq; Enid (OK); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

Biolinq in the United States is seeking a manufacturing engineer to drive qualification, deployment, and sustaining activities across components and finished products. You will lead cross-functional teams to ensure robust production transfer from R&D to manufacturing.

The role requires 5–8 years in high-volume manufacturing, plus experience with design of experiments and lean Six Sigma. The job offers a competitive base salary and comprehensive benefits, with on-site work in the U.S.

Qualifications

• BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required
• Minimum 5-8 years related experience
• Experience in design of experiments and statistical tools (ANOVA, t-test, etc.)
• Experience with Fishbone, A3, 5Y, and other root cause investigation tools
• Experience in high-volume manufacturing operations within medical device, electronics, or biotechnology industries
• General understanding of system interactions between processes
• Strong FDA 21 CFR Part 820 and ISO 13485 knowledge; lean/Six Sigma preferred

Responsibilities

• Support production monitoring with in-process test execution and trending
• Define appropriate alert and action limits based on process performance
• Maintain effectiveness of manual test methods through training and certification
• Assess equipment and process for ergonomics and safety
• Partner with vendors to design tooling for production fixturing
• Identify system-process interactions using standard tools (p-diagram, SIPOC, VSM)
• Design or modify equipment and fixtures for usability and robustness
• Maintain equipment-related documentation and re-qualification activities
• Coordinate with Planning to manage build schedule and material allocation
• Provide guidance and training to operators on engineering and V&V builds

Skills

Manufacturing experience

Design of experiments

Root cause analysis

Lean Six Sigma

Education

BS in engineering or scientific discipline

Tools

Solidworks

MS Project

Visio

JMP

Minitab

ERP/MES

Job description

Biolinq in the United States is seeking a manufacturing engineer to drive qualification, deployment, and sustaining activities across components and finished products. You will lead cross-functional teams to ensure robust production transfer from R&D to manufacturing.

The role requires 5–8 years in high-volume manufacturing, plus experience with design of experiments and lean Six Sigma. The job offers a competitive base salary and comprehensive benefits, with on-site work in the U.S.