Director of Operations - Medical Device

***⚠️ 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 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).