Manufacturing Engineer (Medical Device)

Biointellisense • Golden, CO

3d • $80,000 - $120,000 • Onsite

About The Position

BioIntelliSense is seeking a Manufacturing Engineer to manage verification and validation of devices and software tools. The role collaborates with internal cross-functional teams and external manufacturing partners to support compliance, quality, efficiency, engineering documentation and drawings, and design transfers. The position may be filled at Engineer or Lead level, depending on experience.

The role leads continuous improvement and manufacturing-line setup and optimization at contract manufacturing partners. It also supports make-versus-buy evaluations and transitions of manufacturing or packout in-house, including process validation, equipment and resource planning, and production readiness. Responsibilities include managing product, device, and tool-release verification and validation; developing protocols and SOPs; supporting R&D systems testing and root-cause investigations; and conducting systems and software validation. The Manufacturing Engineer serves as a liaison among Operations, R&D, Product, Regulatory and Quality teams, and external manufacturing partners, while ensuring manufacturing processes and quality criteria meet company standards and procedures comply with safety and environmental regulations.

The role is onsite in Golden, Colorado. The listed salary range is $80,000–$120,000; title and total compensation depend on experience. The application deadline is listed as Nov 31, 2026.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Biomedical, Manufacturing, Industrial, or a related engineering discipline.
• 3–8 years of experience in a manufacturing or industrial engineering environment with offsite or offshore manufacturing partners.
• Medical-device manufacturing experience working within a quality management system, such as ISO 13485 or FDA 21 CFR Part 820.
• Experience with verification and validation of medical devices, software/tools, and systems.
• Proven ability to perform root-cause analysis.
• Excellent communication and project-management skills.
• Knowledge of manufacturing processes, fabrication methods, tool design, and quality-assurance techniques.
• Familiarity with manufacturing equipment and quality-assurance techniques.

Nice To Haves

• Master’s degree in Engineering or an MBA.
• Demonstrated experience building software tools to drive Lean or efficiency improvements, such as with Python, SQL, Power BI, Power Apps, or similar, from defining requirements through deployment and user adoption.
• Experience mentoring or training interns, junior engineers, or technicians.
• Lean Six Sigma Green Belt or Black Belt.
• Experience with electronics/PCBA or high-volume electronics assembly.
• Experience integrating tools with MES/ERP systems or manufacturing test data, and validating software used in production.
• Ability to travel domestically and internationally to manufacturing partners.

Responsibilities

• Lead continuous-improvement initiatives to improve manufacturing efficiency through development and optimization of tools, processes, and software.
• Support manufacturing-line setup and optimization at contract manufacturing partners, including line balancing, cycle-time reduction, and initiatives to improve efficiency and throughput.
• Support make-versus-buy evaluations and develop and execute transition plans when manufacturing or packout moves in-house, including process validation, equipment and resource requirements, and production readiness.
• Manage verification and validation of new product, device, and tool releases.
• Generate protocols and SOPs for final testing, handling, and reporting.
• Support R&D systems testing.
• Conduct systems and software validation.
• Support root-cause investigations.
• Serve as the main liaison among Operations, R&D, Product, Regulatory and Quality teams, and external manufacturing partners.
• Ensure manufacturing processes and quality criteria meet BioIntelliSense standards and that procedures comply with safety and environmental regulations.
• Develop and test effective automated and manual systems.
• Organize and manage manufacturing workflows and resources.
• Collaborate with other engineers, contractors, and suppliers.

Benefits

• Robust medical, dental, and vision plans.
• Short-term and long-term disability insurance plans.
• HSA and flexible spending accounts.
• Safe Harbor 401(k) plan with 3% employer contribution and immediate vesting.
• Flexible vacation plans (FlexVTO), paid sick leave, and 11 company holidays.
• Home-office benefits stipend for fully remote roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level