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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.
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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.
