---
title: 'Director of Operations - Medical Device at Biointellisense'
canonical: 'https://feeny.ai/job/director-of-operations-medical-device-biointellisense-golden-v5peqy3r4jte'
type: 'job'
last_seen: '2026-09-12'
---

# Director of Operations - Medical Device at Biointellisense

- **Company:** Biointellisense
- **Location:** Golden, CO
- **Compensation:** $100k–$145k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-07-15
- **Last confirmed live:** 2026-09-12
- **Apply:** https://jobs.lever.co/biointellisense/2e6a3dcd-d8cd-4cad-9abc-c487449b5167

## Job description

⚠️ Beware of recruiting scams. BioIntelliSense only contacts candidates from @biointellisense.com email addresses. We never conduct interviews over text, email or chat apps. If you receive a message that doesn't match this, treat it as fraudulent and email hr@biointellisense.com to verify.

## About BioIntelliSense

The future of healthcare is here. Join us to shape the future of healthcare for patients and clinicians. BioIntelliSense is helping to decode human physiology and pioneer a new standard of proactive monitoring to improve healthcare outcomes and save lives.

Our FDA-cleared and award-winning BioButton® wearables, BioHub™ gateways, BioMobile™ applications, BioCloud™ data services and the BioDashboard™ clinical intelligence system creates a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. Through our physiologic intelligence and AI-driven analytics, clinicians have access to vital sign trending and data-driven insights to enable earlier detection of patient health decline and proactive intervention for faster, safer care.

_______________________________________________________________________________________________________

## About the Role

The Director of Operations is responsible for leading and coordinating cross-functional programs that drive on-time, on-budget execution of manufacturing and operations initiatives in a regulated medical device environment. This role serves as the central point of accountability for program planning, risk management, and execution across Manufacturing, Quality, Supply Chain, R&D, and Regulatory Affairs. The successful candidate will balance strategic program ownership with hands-on tactical execution to support new product introductions (NPI), sustaining engineering changes, capacity expansion, and continuous improvement initiatives for Class II medical devices.

Job Description & Responsibilities

Operations & Manufacturing

- Partner with Manufacturing Engineering and Operations leadership to optimize production processes, capacity, and throughput.
- Support process validations (IQ/OQ/PQ), equipment qualification, and production line readiness for new and existing products.
- Drive continuous improvement using Lean Manufacturing, Six Sigma, Kaizen, and Value Stream Mapping methodologies.
- Coordinate with Supply Chain to ensure material availability, supplier readiness, and inventory targets aligned with program plans.
- Lead operational readiness reviews and production hand-off activities from development to commercial manufacturing.
- Onsite warehouse employee oversight.

Quality & Regulatory Compliance

- Ensure all program activities comply with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and applicable EU MDR requirements.
- Support Design Transfer, Design Controls, and Design History File (DHF) deliverables in coordination with R&D and Quality.
- Drive engineering change orders (ECOs), CAPAs, and nonconformance resolutions through to closure with operational impact assessments.
- Partner with Regulatory Affairs to ensure program plans align with 510(k) submission timelines, post-market surveillance, and labeling requirements for Class II devices.
- Support internal, supplier, and external audits (FDA, Notified Body) as the Operations program lead.

Leadership & Communication

- Facilitate cross-functional core team meetings, steering committee reviews, and executive program updates.
- Influence without direct authority across engineering, quality, supply chain, and external partners.
- Translate technical and regulatory complexity into clear, actionable communication for both technical teams and senior leadership.
- Mentor junior team members and contribute to building program management best practices and tools across the organization.

Job Requirements

Education & Experience

- Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Electrical), Operations Management, Supply Chain, or related technical discipline.
- 6–9 years of progressive experience in program management, project management, or operations within the medical device industry.
- Demonstrated experience managing complex, cross-functional programs from initiation through commercialization.
- Hands-on experience supporting medical device manufacturing operations (assembly, packaging, sterilization, or similar).
- Proven track record of delivering programs on time, on scope, and on budget in a regulated environment.

Technical & Regulatory Knowledge

- Working knowledge of medical device manufacturing processes, production transfer, and operational scale-up.
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and design control requirements for Class II medical devices.
- Familiarity with 510(k) submission processes and post-market regulatory obligations.
- Experience with engineering change control, document control systems (e.g., Greenlight Guru, Arena, Agile, MasterControl), and ERP/MRP systems (e.g., NetSuite, SAP, Oracle).
- Understanding of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.

## Skills & Competencies

- Proficient in program management tools (MS Project, SmartSheet, Jira, Asana, or equivalent).
- Advanced proficiency in MS Office Suite (Excel, PowerPoint, Word, Outlook); experience with Power BI or Tableau is a plus.
- Strong analytical, problem-solving, and decision-making skills with a data-driven mindset.
- Excellent written and verbal communication skills, including the ability to present to executive leadership.
- Demonstrated ability to manage competing priorities and drive results in a fast-paced, matrixed environment.
- Strong organizational, time management, and attention-to-detail skills.

Work Environment & Physical Requirements

- Ability to work in both office and warehouse environments.
- Occasional travel to supplier sites, contract manufacturers, or other company locations.
- Ability to lift up to 25 lbs and stand for extended periods when supporting production floor activities.

Nice to Haves

- Master's degree in Engineering, Operations Management, MBA, or related field.
- PMP, PgMP, or equivalent program/project management certification.
- Lean Six Sigma certification (Green Belt or Black Belt).
- Experience with Class II medical devices.
- Experience supporting FDA inspections or Notified Body audits in a leadership capacity.
- Experience with international manufacturing, contract manufacturing, or global supply chain operations.
- Experience supporting EU MDR transitions or international regulatory submissions (Health Canada, PMDA, NMPA, ANVISA).
- Experience with electromechanical or software-enabled medical devices (SaMD/SiMD).
- Working knowledge of cybersecurity considerations for connected medical devices (IEC 62304, FDA cybersecurity guidance).

Company Culture and Benefits

Our Workplace Culture: We’re a dynamic remote-first environment, with offices in Golden, CO and Redwood City, CA and a talented, motivated team of colleagues globally. We’re passionate about BioIntelliSense and are motivated by our shared mission. As OneBioTeam, we’re a collaborative team that thrives in a fast-paced environment and embraces challenges as opportunities to shape the future, together.

Comprehensive Benefits Package:

- Robust Medical, Dental and Vision Plans
- STD, LTD, Insurance Plans
- HSA and Flexible Spending Accounts
- Safe Harbor 401(k) Plan with 3% Employer Contribution with immediate vesting
- FlexVTO (flexible vacation plans), Paid Sick Leave, 11 Company Holidays
- Home Office Benefits Stipend for Fully Remote Roles

BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.

## About Biointellisense

## Company Overview
- **One-liner**: BioIntelliSense provides medical-grade wearable devices and a data-as-a-service (DaaS) platform for continuous remote patient monitoring in hospitals and at home.
- **Entity Type**: Private (Series C)
- **Headquarters**: Golden, Colorado, United States
- **Founded**: 2019
- **Founders**: David Wang (Co-Founder, CEO) and James Mault, MD, FACS (Co-Founder, Executive Chairman)

## Core Business
- **Primary industry/industries**: Remote Patient Monitoring (RPM), Medical Devices, Healthcare IT, Clinical Intelligence
- **Target customers**: B2B — U.S. health systems, hospitals, skilled nursing facilities, and home health organizations
- **Mission or purpose statement**: To improve and save lives by pioneering a new standard of scalable proactive monitoring, enabling better outcomes while reducing the cost of care [biointellisense.com](https://www.biointellisense.com/company/).

## Products & Services
- **[BioButton®]**: An FDA-cleared, medical-grade wearable device (adhesive patch) that continuously captures multi-parameter vital signs, physiological biometrics, and symptomatic events. Designed for in-hospital and at-home use with an effortless patient experience.
- **[BioDashboard®]**: A clinical analytics and reporting platform that provides high-resolution patient trending, early deterioration detection alerts, and decision support for clinicians.
- **Data-as-a-Service (DaaS) Platform**: The backend engine that securely captures, transmits, and analyzes patient data to enable scalable remote monitoring.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed.
- **Key Metric**: Total Funding — **$143.15M** raised across multiple rounds [cbinsights.com](https://www.cbinsights.com/company/biointellisense). Most recent round: **$58.35M Series C closed ~8 months ago**. Annual revenue is estimated at $8.4M [linkedin.com](https://linkedin.com/company/biointellisense).
- **Notable Investors/Partners**: Fresenius Medical Care North America, Chimera Investments, Pendrell, CU Healthcare Innovation Fund, Jim Murren, and the U.S. Department of Defense. Strategic partnerships include Hicuity Health for scalable end-to-end continuous monitoring [businesswire.com](https://www.businesswire.com/news/home/20250217426353/en/BioIntelliSense-Partners-with-Hicuity-Health-to-Offer-Scalable-End-to-End-Continuous-Patient-Monitoring-for-U.S.-Health-Systems).
- **Growth Signals**: Completed an inpatient expansion with **Houston Methodist** (2024); published an observational study in the *Journal of Clinical Medicine* showing early detection of patient deterioration with the BioButton®; has 22 filed patents; workforce distributed across 7 countries.

## Competitive Advantages
- **FDA-Cleared Medical Grade**: The BioButton is FDA-cleared—a high regulatory bar that creates a significant moat against consumer-grade wearables.
- **End-to-End Platform**: Combines hardware (wearable), software (dashboard/analytics), and data services in one integrated DaaS platform, reducing integration complexity for health systems.
- **Scalable Model**: Designed for both in-hospital and at-home use across large patient populations, addressing the industry shift toward decentralized care.
- **Strong IP Portfolio**: 22 patents covering sensors, cardiology, and computer bus technologies.

## Strategic Focus
- **Expansion into large health systems**: Deepening existing partnerships (e.g., Houston Methodist) and forming new ones (e.g., Hicuity Health).
- **Clinical evidence generation**: Publishing peer-reviewed studies to validate the clinical and economic value of continuous monitoring.
- **Product development**: Continued iteration on the BioButton and BioDashboard, likely incorporating AI-based analytics for earlier deterioration detection.

## Why Work Here
- **High-impact mission**: Directly contribute to reducing patient deterioration and saving lives through proactive monitoring.
- **Hybrid/Remote/On-site options**: The company offers flexibility—roles include on-site in Golden, CO (Operations), hybrid in Redwood City, CA (DevOps), and fully remote positions within the US (Customer Success) [jobs.lever.co](https://jobs.lever.co/biointellisense).
- **Notable Engineering Culture**: Under Chief Technology Officer Marshal Dhillon; tech stack includes Flutter, Python, GitHub Actions, Auth0, and MongoDB Atlas.
- **Workforce diversity**: Small team (~76 employees) with a distributed, international footprint—opportunity for broad impact.
- **Caution**: Company reviews on employer rating sites indicate a 2.7/5.0 overall rating with concerns about culture (2.9) and career growth (2.8), though work-life balance (3.2) and compensation (3.1) are rated higher. Recent headcount declined ~14% year-over-year, which may indicate restructuring.

## Sources
1. [biointellisense.com - Company page](https://www.biointellisense.com/company/)
2. [biointellisense.com - Careers page](https://www.biointellisense.com/careers/)
3. [jobs.lever.co - Official job listings](https://jobs.lever.co/biointellisense)
4. [linkedin.com - BioIntelliSense company profile](https://linkedin.com/company/biointellisense)
5. [cbinsights.com - BioIntelliSense profile](https://www.cbinsights.com/company/biointellisense)
6. [businesswire.com - Partnership with Hicuity Health](https://www.businesswire.com/news/home/20250217426353/en/BioIntelliSense-Partners-with-Hicuity-Health-to-Offer-Scalable-End-to-End-Continuous-Patient-Monitoring-for-U.S.-Health-Systems)
7. [businesswire.com - Study publication in Journal of Clinical Medicine](https://www.businesswire.com/news/home/20241125006564/en/BioIntelliSense-Announces-Observational-Study-in-Journal-of-Clinical-Medicine-Demonstrating-Early-Detection-of-Patient-Deterioration-with-FDA-cleared-BioButton%C2%AE-Continuous-Monitoring-Wearable-Device)

## Other roles at Biointellisense

- [Vice President, Growth](https://feeny.ai/job/vice-president-growth-biointellisense-united-states-xp6ssvc8g8wp) — United States
- [Customer Success Project Manager](https://feeny.ai/job/customer-success-project-manager-biointellisense-united-states-tgg5tg9nt1tz) — United States
- [Operations Technician](https://feeny.ai/job/operations-technician-biointellisense-golden-g00xmj8w2ed7) — Golden, CO