Senior Manufacturing Manager at Biolinq Incorporated – San Diego, California

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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:

This role is responsible for leading daily manufacturing operations while building scalable processes, systems, and team capability to support future commercial growth. Ensures safe, compliant, and high-quality, and cost-effective production. Operates in a highly dynamic startup environment and must balance hands-on operational execution with strategic infrastructure development to support transition from development / early production into commercial manufacturing scale. Leads people, builds processes, and is a cross-functional partner who can establish structure without slowing innovation and can grow into broader operational leadership over time.

Duties and Responsibilities:

Manufacturing Operations & Planning

• Oversee day-to-day manufacturing operations, ensuring production schedules are met to satisfy commercial demand and clinical supply needs.
• Partner with Quality, Engineering, Supply Chain, and Regulatory teams.
• Own the site's production and capacity planning, optimizing labor, equipment, and material resources to align with sales forecasts and business objectives.
• Manage the master production schedule, coordinating with supply chain and procurement to ensure material availability and mitigate supply risks.
• Establish and track key performance indicators (KPIs) for safety, quality, delivery, cost, and inventory (SQDCI), driving daily management and accountability.

Quality & Regulatory Compliance

• Ensure all manufacturing activities are performed in strict compliance with FDA 21 CFR 820, ISO 13485, and other applicable domestic and international regulatory requirements.
• Foster a "Quality First" culture, partnering closely with Quality Assurance to maintain the facility's readiness for internal and external audits.
• Oversee the development and maintenance of manufacturing documentation, including Device History Records (DHRs), work instructions, and batch records.

Continuous Improvement & Scale-Up

• Lead the transition of new products from development into commercial manufacturing, utilizing Design for Manufacturability (DFM) principles.
• Drive the implementation of Lean manufacturing and Six Sigma methodologies to reduce waste, optimize throughput, and improve Overall Equipment Effectiveness (OEE).
• Lead process validation activities (IQ/OQ/PQ) and champion root cause analysis and corrective action (CAPA) for manufacturing-related issues.
• Implement process automation when appropriate.

Team Leadership & Development

• Hire, coach, lead, mentor, and develop a growing team of manufacturing associates, production supervisors, planners and technicians.
• Build career paths and skill matrices for manufacturing roles.
• Cultivate a culture of safety, engagement, continuous learning, accountability, and ownership, ensuring all team members are trained and empowered to solve problems at the source.
• Manage departmental budgets, headcount planning, and performance reviews to build a high-performing operations team.

Qualifications:

• Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related field.
• Minimum of 10 years plus of progressive experience in manufacturing operations, with at least 3-5 years in a leadership role within the medical device industry.
• Proven experience in a highly regulated environment (FDA/ISO 13485) is required; experience with combination products or electro-mechanical devices is a strong plus.
• Experience in high-volume manufacturing scale-up and commercial launch is highly desirable. Experience in early-stage, startup, or high-growth environment is strongly preferred. Experience scaling manufacturing from pilot to higher volume preferred.
• Deep knowledge of Lean Manufacturing, Six Sigma (Green or Black Belt preferred), and process validation.
• Strong understanding of production planning, ERP/MRP systems (e.g., SAP, Oracle), and inventory management principles.
• Demonstrated ability to lead, inspire, and develop teams through periods of rapid growth and change.
• Excellent problem-solving, analytical, and decision-making skills with a hands-on, "in the trenches" leadership style.
• Outstanding communication and interpersonal skills, with the ability to collaborate cross-functionally with R&D, Quality, and Commercial teams.
• Demonstrated Evidence being a strong team builder with integrity, resilience, curiosity and empathy.
• Soft Skills: High ownership mindset; comfortable with ambiguity and change; strong decision-making; ability to influence without authority; calm and solution-oriented under pressure; strong communication across technical and non-technical audiences; emotional intelligence and strong people judgment; grow mindset and learning agility.
• Supervisory and Leadership Skills: Performance management and coaching capability; conflict resolution and employee relations judgment; workforce planning and staffing strategy; change management leadership; developing first-line supervisors and future leaders; leading through rapid company growth phases; building structure without creating bureaucracy.
• Technical Skills: Medical device or regulated manufacturing environment experience. Knowledge of: GMP/QSR/ISO quality environments; process validation concepts; manufacturing documentation systems; production planning concepts; root case analysis tools; lean manufacturing principles. Experience scaling production volume.
• Start-up Specific Capabilities: Builds processes from scratch; comfortable wearing multiple hats; strong prioritization skills; resourceful with limited resources; balances speed with compliance; understands when to implement structure vs remain flexible.
• Knowledge Requirements: Regulated manufacturing lifecycle; production flow and material control; capacity modeling and production scaling; workforce skill development and training systems; risk-based decision making; audit readiness and documentation discipline.

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.

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: $140,000 to $170,000 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 Careers@biolinq.com