Director of Operations

The future of healthcare is here. Join us to shape the future of healthcare for patients and clinicians. Bio Intelli Sense  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 Bio Button multiparameter wearables, Bio Hub gateways, Bio Mobile downloadable applications, Bio Cloud data services and the Bio Dashboard 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 high-resolution vital sign trending and data-driven insights to enable earlier detection of patient deterioration and proactive intervention for better, safer care.

We're a remote-first, lean start-up environment and our global Bio Team colleagues are growth-oriented, collaborative and passionate about our mission and the future of Bio Intelli Sense . We thrive in a fast-paced environment and embrace challenges as opportunities to shape the future, together.

_______________________________________________________________________________________________________

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, Master Control), and ERP/MRP systems (e.g., Net Suite,…