Director of Operations in Golden, Colorado at Biointellisense Inc.

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.