Director of Operations

About BioIntelliSense

BioIntelliSense is pioneering advanced healthcare technologies designed to improve patient outcomes through continuous physiologic monitoring. Our FDA-cleared wearable BioButton®, supporting gateway and app technologies, and cloud data platform empower clinicians with vital sign monitoring and AI-driven insights to aid earlier detection of patient conditions for proactive care.

We operate as a remote-first, lean startup with a global team that embraces challenges and prioritizes collaboration and growth in a fast-paced environment.

Role Overview

The Director of Operations will oversee cross-departmental manufacturing and operational programs ensuring on-time, budget-aligned execution within a regulated medical device framework. This position acts as the primary program lead for planning, risk management, and execution connecting Manufacturing, Quality, Supply Chain, R&D, and Regulatory Affairs to support new product launches, sustaining changes, capacity growth, and continuous improvement initiatives for Class II devices.

Key Responsibilities

• Collaborate with Manufacturing Engineering and Operations leadership to refine production processes, maximize capacity and throughput.
• Lead validations including IQ/OQ/PQ, equipment qualifying, and prepare production lines for product launches and ongoing manufacturing.
• Apply Lean, Six Sigma, Kaizen, and value stream methodologies to drive process improvements.
• Coordinate with Supply Chain for material readiness, supplier alignment, and inventory management per program demands.
• Manage operational readiness reviews and the transition from development to commercial manufacturing.
• Oversee onsite warehouse personnel to ensure operational efficiency.
• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR standards in all program facets.
• Support design transfer, documentation control, engineering changes, CAPAs, and nonconformance resolution collaborating with R&D and Quality teams.
• Partner with Regulatory Affairs ensuring alignment with 510(k) submissions, post-market surveillance, and labeling for Class II devices.
• Lead operational aspects of internal, supplier, and regulatory audits.
• Facilitate cross-functional team meetings, steering committees, and provide updates to executive leadership.
• Influence and collaborate across departments without direct authority and mentor junior staff.
• Develop and share best practices for program management tools and methods.

Qualifications and Experience

• Bachelor’s degree in relevant Engineering fields, Operations Management, Supply Chain or similar disciplines.
• 6 to 9 years of advancing experience managing complex programs in medical device operations or project management.
• Hands-on knowledge of manufacturing operations including assembly, packaging, and sterilization.
• Proven track record delivering cross-functional programs on schedule, scope, and budgets under regulatory compliance.
• Familiarity with manufacturing scale-up and production transfers.
• Strong understanding of FDA, ISO, and EU medical device regulations and standards.
• Experience with 510(k) processes and post-market compliance requirements.
• Use of engineering change control and document/ERP systems such as Greenlight Guru, Arena, Agile, MasterControl, NetSuite, SAP, or Oracle.
• Expertise in Lean, Six Sigma and continuous process improvement approaches.

Skills and Competencies

• Proficient with project and program management tools like MS Project, SmartSheet, Jira, or Asana.
• Advanced user of MS Office products; familiarity with Power BI or Tableau is advantageous.
• Strong analytical and problem-solving abilities—with data-driven decision skills.
• Excellent communication capabilities suited for technical teams and senior executives.
• Ability to manage multiple priorities efficiently in a dynamic, matrixed set-up.
• Great organizational skills and meticulous attention to detail.

Work Setting and Physical Requirements

• Work involves both office and warehouse environments.
• May require occasional travel to suppliers, contract manufacturers, or other offices.
• Physical capability to lift up to 25 pounds and remain standing for extended periods while supporting production.

Preferred Additional Qualifications

• Master’s degree in Engineering, Operations Management, MBA or related fields.
• Certifications such as PMP, PgMP, or Lean Six Sigma Green/Black Belt.
• Experience with Class II medical devices and leadership during FDA inspections or Notified Body audits.
• Background in international and contract manufacturing or global supply chain.
• Knowledge of EU MDR, international regulatory submissions, and cybersecurity for connected medical devices.

Culture and Benefits

As a part of BioIntelliSense’s remote-first but collaborative culture, employees enjoy a dynamic startup atmosphere with strong shared mission values across offices in Colorado and California. The benefits include comprehensive medical, dental, vision coverage, insurance plans, HSAs, flexible spending accounts, 401(k) with employer contribution, flexible vacation, sick leave, company holidays, and home office stipends.

Equal Opportunity and Data Use Notice

BioIntelliSense is committed to equal employment opportunities without discrimination. The hiring process may use artificial intelligence tools for some application assessments, but final decisions rest with human recruiters. Applicants can inquire about data processing policies.

Compensation and Location

Salary is determined by experience and reflects total compensation. The position is based onsite at Golden, Colorado with remote work options available.