Biointellisense
Director of Operations
Golden, Colorado · Director
Sponsorship not specified$100k-$145kDetected 7 days ago
Data VisualizationCybersecurityComplianceProject ManagementJiraExcelSAPOperations ManagementSupply ChainProcess ImprovementERPControlsFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingTime ManagementMicrosoft OfficeNetSuiteLean ManufacturingRegulatory Affairs
About the role
- 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.
- 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.
Responsibilities
- 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.
- Lead operational readiness reviews and production hand-off activities from development to commercial manufacturing.
- 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.
- Influence without direct authority across engineering, quality, supply chain, and external partners.
- Mentor junior team members and contribute to building program management best practices and tools across the organization.
Requirements
- Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Electrical), Operations Management, Supply Chain, or related technical discipline.
- Experience with engineering change control, document control systems (e.g., Greenlight Guru, Arena, Agile, MasterControl), and ERP/MRP systems (e.g., NetSuite, SAP, Oracle).
Compensation
- $100k-$145k
Benefits
- 6-9 years of progressive experience in program management, project management, or operations within the medical device industry.
- Hands-on experience supporting medical device manufacturing operations (assembly, packaging, sterilization, or similar).
- 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.
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