Senior Manager Pilot Operations

Biolinq Incorporated; San Diego (CA); Hybrid; USD 160,000 - 180,000; Full time

Benefits offered by this job

Medical

Dental

Vision

HSA

FSA

Life Insurance

Long-term Disability

401(k)

Holidays

PTO

Job summary

Biolinq Incorporated in San Diego seeks a Pilot Operations leader to guide NPI and technology transfer from R&D to manufacturing for our intradermal biosensor platform.

You will set priorities, build teams, manage budgets, and drive process validation (IQ/OQ/PQ/PPQ), while improving yield and ensuring FDA 21 CFR 820 and ISO 13485 compliance in a hybrid on-site role.

Qualifications

• BS in Engineering, Chemistry, or related field.
• Experience in pilot operations, NPI and technology transfer.
• Strong knowledge of cGMP, FDA Part 820, ISO 13485.
• Proven leadership, communication and problem-solving skills.

Responsibilities

• Plans, manages, and coordinates all operational activities within Pilot Operations.
• 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, manage workload, training and performance.

Skills

Pilot operations leadership

NPI

Technology transfer

Lean Six Sigma

Regulatory compliance

Education

BS in Engineering, Chemistry, or related field

Tools

Process Validation Methods

GMP Systems

Job description

Description

About the Company

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.

Job Purpose:

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.

Duties and 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.

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
• PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.

As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. 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. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.

Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at [e-mail]