Remote-First Operations Director, Med Tech

BioIntelliSense, Inc; Golden (CO); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical, Dental, Vision

STD/LTD

HSA

401(k) Employer contrib

Flexible vacation

Home office stipend

Job summary

BioIntelliSense, Inc. in Golden, CO, is seeking a Director of Operations to lead cross‑functional programs across manufacturing, quality, supply chain, and R&D in a regulated medical device environment.

The role focuses on on‑time, on‑budget execution for new product introductions, sustaining engineering changes, capacity expansion, and continuous improvement initiatives for Class II devices. Requires strong leadership and regulatory knowledge.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 6–9 years in program/operations management in the medical device industry.
• Experience leading cross‑functional programs from initiation to commercialization.
• Hands‑on experience with medical device manufacturing operations.
• Proven track record delivering programs on time and on budget in a regulated environment.

Responsibilities

• Lead cross‑functional programs across Manufacturing, Quality, Supply Chain, R&D, and Regulatory.
• Drive process validations and production readiness for new products.
• Lead continuous improvement using Lean, Six Sigma, Kaizen, and Value Stream Mapping.
• Coordinate with Supply Chain for material availability and inventory targets.
• Lead operational readiness reviews and production hand‑off activities from development to commercial manufacturing.
• Mentor junior team members and build PM best practices.

Skills

Program management

Cross-functional leadership

Lean Six Sigma

Data-driven decision making

Education

Bachelor's degree in Engineering

Tools

MS Project

SmartSheet

Jira

Asana

Power BI

Tableau

NetSuite

SAP

Oracle

Job description

BioIntelliSense, Inc. in Golden, CO, is seeking a Director of Operations to lead cross‑functional programs across manufacturing, quality, supply chain, and R&D in a regulated medical device environment.

The role focuses on on‑time, on‑budget execution for new product introductions, sustaining engineering changes, capacity expansion, and continuous improvement initiatives for Class II devices. Requires strong leadership and regulatory knowledge.