Director of Operations - Medical Device
Overview
Lead cross-functional operations initiatives driving on-time on-budget manufacturing and program execution for regulated medical devices. Serve as central accountability for Manufacturing Quality Supply Chain R&D and Regulatory Affairs. Optimize production processes enhance throughput and implement continuous improvement methodologies.
What You'll Do18
- 1Partner with Manufacturing Engineering to optimize production processes capacity and throughput
- 2Support process validations equipment qualifications and production line readiness for new and existing products
- 3Drive continuous improvement using Lean Manufacturing Six Sigma Kaizen and Value Stream Mapping
- 4Coordinate with Supply Chain to ensure material availability supplier readiness and inventory alignment
- 5Lead operational readiness reviews and production hand-off activities from development to commercial manufacturing
- 6Oversee onsite warehouse employee supervision
- 7Ensure compliance with FDA 21 CFR Part 820 ISO 13485 and EU MDR requirements
- 8Support design transfer design controls and DHF deliverables with R&D and Quality
- 9Drive engineering change orders CAPAs and nonconformance resolutions with operational impact assessments
- 10Partner with Regulatory Affairs to align program plans with 510(k) submission timelines post-market surveillance and labeling requirements
- 11Support internal supplier and external audits including FDA Notified Body activities
- 12Facilitate cross-functional meetings steering committee reviews and executive updates
- 13Mentor junior team members and develop program management best practices
- 14Manage complex cross-functional programs from initiation through commercialization
- 15Provide hands-on support for assembly packaging sterilization and other manufacturing operations
- 16Deliver programs on time on scope and on budget in regulated environments
- 17Maintain strong analytical problem-solving skills with data-driven decision making
- 18Communicate effectively with technical teams and senior leadership
Requirements12
- 15+ years building ETL pipelines with Spark and Airflow
- 26–9 years progressive experience in program management within medical device industry
- 3Bachelors degree in Engineering or related technical discipline
- 4Demonstrated experience managing complex cross-functional programs from initiation through commercialization
- 5Hands-on experience supporting medical device manufacturing operations
- 6Proven track record of delivering programs on time on scope and on budget
- 7Familiarity with FDA 21 CFR Part 820 ISO 13485 ISO 14971 and design control requirements
- 8Strong understanding of 510(k) submission processes and post-market regulatory obligations
- 9Experience with engineering change control document control systems and ERP/MRP systems
- 10Knowledge of Lean Manufacturing Six Sigma and continuous improvement methodologies
- 11Proficiency in program management tools such as MS Project SmartSheet Jira Asana or equivalent
- 12Advanced proficiency in Excel Power BI or Tableau preferred
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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