Senior Manager Pilot Operations

About the Role

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 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, and process improvement. 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.

Responsibilities

• Plans, manages, and coordinates all aspects of operational activities within the 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.

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.

Working Conditions

• Willingness and ability to work on site.
• May have business travel up to 10% in a year.
• Hybrid role primarily based in a professional office setting, with routine time required in a laboratory environment. The lab environment may include exposure to chemicals, fumes, biohazardous materials, and low-to-moderate noise levels.
• Must follow all safety protocols (PPE), including lab coats, gloves, and safety glasses.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.

Benefits

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

Pay

The U.S. base salary range reasonably expected to be paid for this role is $160,000 to $180,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans.