Director of Operations - Medical Devices, Remote-First

Medium; Golden (CO); On-site; USD 100,000 - 145,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Home Office stipend

Paid holidays

Job summary

BioIntelliSense in Golden, CO is seeking a Director of Operations to lead cross-functional programs across Manufacturing, Quality, Supply Chain, R&D, and Regulatory Affairs for Class II medical devices.

You will balance strategic ownership with hands-on execution to support NPI, sustaining changes, capacity expansion, and continuous improvement while driving timely, on‑budget delivery in a regulated environment.

Qualifications

• Bachelor's degree in engineering or related field required.
• 6–9 years of progressive program/ops management in the medical device industry.
• Experience managing cross-functional programs from initiation to commercialization.
• Hands-on experience supporting medical device manufacturing operations.
• Proven track record delivering programs on time, on scope, and on budget in a regulated environment.

Responsibilities

• Lead cross-functional programs for manufacturing and operations initiatives.
• Coordinate with Manufacturing, Quality, Supply Chain, R&D, and Regulatory Affairs.
• Drive process validations, equipment qualification, and line readiness for new and existing products.
• Lead readiness reviews and production hand-off activities from development to commercial manufacturing.
• Mentor junior team members and contribute to PM best practices and tools.

Skills

Program management

Cross-functional leadership

Regulatory compliance

Lean Six Sigma

Data-driven

Education

Bachelor's degree in Engineering

Tools

MS Project

SmartSheet

Jira

Asana

Power BI

Tableau

ERP/MRP Systems

Job description

BioIntelliSense in Golden, CO is seeking a Director of Operations to lead cross-functional programs across Manufacturing, Quality, Supply Chain, R&D, and Regulatory Affairs for Class II medical devices.

You will balance strategic ownership with hands-on execution to support NPI, sustaining changes, capacity expansion, and continuous improvement while driving timely, on‑budget delivery in a regulated environment.