Senior Manager Pilot Operations
About The Position
Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. Pilot Operations serves as a critical function between R&D/Engineering and Commercial Manufacturing departments to support new product development, new product introduction (NPI), technology transfer, process improvement, etc. This position will set goals, establish priorities, manage resources, develop concepts and approaches, review project progress and results, and make management decisions. Operational activities may include planning, designing/developing, building, analyzing/investigating or any other aspect of pilot operations work. Transitioning from early-stage processes to robust, automated, and cost-efficient production systems while maintaining the highest standards of quality, compliance, and product performance.
Requirements
- BS in Engineering, Chemistry, or related field
- Minimum of 8-10 years of progressive experience in manufacturing operations, with at least 3-5 years in a leadership role within the medical device industry.
- Extensive experience in pilot operations, NPI, and technology transfer
- Strong understanding of cGMP, FDA Part 820, ISO 13485
- Strong communication, leadership, and problem-solving skills
- Proficient understanding and ability to establish key metrics and measures of performance
Responsibilities
- Plans, manages, and coordinates all aspects operational activities within Pilot Operations functional area.
- Drive New Product Introduction (NPI) and technology transfer from development to manufacturing.
- Support and execute process validation strategies (IQ/OQ/PQ/PPQ) for product commercialization.
- Establish KPIs for Pilot Operations (yield, OEE, cycle time, defect rate).
- Implement Lean Six Sigma and continuous improvement initiatives to improve yield and efficiency.
- Build and lead high-performing teams. Manages subordinate personnel including hiring, determining workload and delegating assignments, training, monitoring and evaluating performance, coaching, initiating corrective or disciplinary actions, and establishing and sustaining long-term human resources and skill requirements for the various pilot operations teams.
- Ensure all Pilot Operations activities are performed in compliance with FDA 21 CFR 820, ISO 13485, and other applicable domestic and international regulatory requirements.
- Partner on automation strategies including semi-automated and fully automated production.
- Partner cross-functionally to support clinical studies, regulatory approvals, and commercial launch.
- Drive cost of goods reduction while maintaining product quality and compliance.
- Assist annual and semi-updated departmental budgeting activities.
- This position assumes and performs other duties as assigned.
Benefits
- Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
