Manufacturing Engineer — Continuous Improvement & Validation

BioIntelliSense, Inc; Golden (CO); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Remote-friendly culture

Home Office Benefits Stipend

Comprehensive health plans

401(k) with employer contrib.

Job summary

BioIntelliSense, Inc. seeks a Manufacturing Engineer to manage verifications and validations of devices and software tools, collaborating with internal and external partners to ensure quality, compliance, and efficiency in manufacturing processes.

The role can be at Engineer or Lead level depending on experience, with responsibilities spanning tool development, line optimization, process validation, and cross-functional liaison across Operations, R&D, and Regulatory teams.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, BioMedical, Manufacturing, Industrial, or related engineering.

Responsibilities

• Lead continuous improvement initiatives to enhance manufacturing efficiency through tools, processes and software.
• Support CM partner line setup and optimization for throughput gains.
• Develop and execute transition plans for make-versus-buy when transitioning manufacturing in-house.
• Manage verifications and validations of new products/devices/tools releases.
• Generate protocols and SOPs for final testing, handling, and reporting.
• Support R&D systems testing and conduct systems/software validation.
• Collaborate with Operations, R&D, Product and Regulatory/Quality teams and external partners.
• Ensure processes meet BioIntelliSense standards and safety/environmental regulations.
• Develop and test automated and manual systems; organize workflows and resources.

Skills

Manufacturing engineering

Process improvement

Project management

Root cause analysis

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Mechanical/ Electrical/ BioMedical/ Manufacturing/ Industrial engineering

Tools

Python

SQL

Power BI

MES/ERP

Job description

BioIntelliSense, Inc. seeks a Manufacturing Engineer to manage verifications and validations of devices and software tools, collaborating with internal and external partners to ensure quality, compliance, and efficiency in manufacturing processes.

The role can be at Engineer or Lead level depending on experience, with responsibilities spanning tool development, line optimization, process validation, and cross-functional liaison across Operations, R&D, and Regulatory teams.