General Manager Medical and Life Science Instruments

General Manager Medical and Life Science Instruments Lumatas Biosystems Inc Milpitas, CA Job Details Full-time 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Developing medical devices Revenue growth Mandarin Manufacturing management Managerial strategic planning Strategic management 7 years 6 years Operations management Preventive maintenance Bachelor's degree in electrical engineering Logistics management Robotic systems Sales Product roadmapping Adverse event reporting Embedded systems ISO standards 5 years Bachelor of Science Identifying new business opportunities Engineering Regulatory compliance Firmware Employee retention Production inventory management GMP Immunohistochemistry Electrical engineering Improving operational efficiency 3 years Compliance management implementation 8 years Team development Key Performance Indicators Business development Managing budgets in a finance role Financial operations management Bachelor's degree in mechatronics Bachelor's degree Continuous improvement Production planning Embedded software Decision making Master of Science Systems engineering Profit & Loss statement Recruiting Software development Quality standards in production Sales strategy Master's degree in electrical engineering System architecture design Bachelor of Engineering Product strategy 1 year Manufacturing Root cause analysis Senior level Electrical Engineering Strategic partnerships 4 years Cross-functional collaboration Profit and loss analysis Cross-functional team management Leadership 2 years Cross-functional communication Organizational budget management FDA regulations Senior leadership Product lifecycle management Full Job Description General Manager

• Medical & Life Science Instruments Milpitas, CA | Senior Management SUMMARY We are seeking a technically deep General Manager to lead our hardware and software engineering teams in the development and lifecycle management of our precision diagnostic instruments (autostainers
• Class 1) and reagents used in histology and pathology laboratories worldwide.

This is a high-impact P&L leadership role requiring a rare combination of engineering and software leadership, manufacturing excellence, scientific literacy, regulatory expertise, and organizational leadership. The ideal candidate bridges the worlds of science and commerce. The ability to engage credibly with scientists and engineers while driving excellence in operational and financial performance. This position reports directly to the President.

KEY RESPONSIBILITIES

Strategic Leadership & Financial Management Own the full P&L for the autostainer business, driving revenue growth, margin improvement, and long-term market position. Help define and execute business strategy, including product roadmap, market expansion, and competitive positioning. Set annual operating plans, budgets, and KPIs. Manage headcount and facility space to support existing and future business needs. Assist in identifying, developing and supporting new sales partnerships. Technical Leadership & Product Development Lead the technical vision for hardware and software across the autostainer platform including embedded systems, device drivers, run times and application software based on market needs and competitive gaps. Lead the design and development of embedded software controlling fluidic systems, motion control, optical scanners, RFID and thermal management

• all core to autostainer operation.

Actively participate and provide technical leadership in architecture reviews, design decisions, critical code and hardware reviews for product development initiatives. Drive root cause analysis on hardware failures, software defects, manufacturing problems and field issues. Maintain deep understanding of staining science (H&E, IHC, ISH, FISH, special stains) and the fluidics, robotics, and software platforms that drive autostainer performance. Define and enforce engineering standards for firmware quality, hardware-software integration, testing practices, and documentation across the team. Operations & Manufacturing Oversee manufacturing operations with accountability for realistic schedules, quality, throughput, cost, and delivery performance. Ensure good manufacturing practices (GMP) and compliant production of instruments and reagents, meeting ISO 13485 and applicable regulatory standards (UL/FDA). Manage supply chain complexity including assurance of supply, part obsolescence, critical raw material sourcing and logistics. Drive continuous improvement in field serviceability, manufacturing costs, preventive maintenance programs, and instrument performance. Quality & Regulatory Compliance (Class 1) Maintain regulatory compliance across all markets, UL/CE marking, and IVDR (EU) for IVD-classified devices. Champion a culture of quality, ensuring robust QMS systems and ISO/UL audit readiness. Oversee adverse event reporting, recall procedures, and product liability risk management. People & Organization Recruit, develop, and retain talent across technical, operations, and regulatory functions. Build a team culture that values collaboration, rigor, domain curiosity, peer review and continuous improvement aligned to customer needs and business results. Lead cross-functional alignment across Engineering, Software, Manufacturing, Supply Chain, Regulatory, and Accounting.

QUALIFICATIONS

Required BS or MS in electrical engineering, mechatronics, software, life sciences or related field. Ability to communicate in Mandarin. 10+ years of progressive engineering leadership experience; preferably in medical devices, diagnostics, or life science instrumentation. Strong experience with hardware-software co-development along with managing the interface between hardware, firmware and application software. Robust hardware knowledge, expertise in embedded systems development and participate meaningfully in hardware design reviews. Demonstrated P&L ownership with a track record of revenue growth and operational improvement. Strong working knowledge of UL/FDA regulatory and QMS processes, IVD classifications, GMP, ISO 13485 and Class 1 general controls under 21 CFR Part 820. Preferred Direct experience with autostainer, slide staining, or IHC/ISH platform businesses. Experience with optical or imaging systems, reagent delivery systems or thermal controls in an instrument context. Familiarity with competitive landscape including Leica/Danaher, Ventana/Roche, and Dako/Agilent. Experience with reagent rental/lease commercial models and capital equipment evaluation processes. International commercial experience and global distribution management. Experience in navigating CE marking and IVDR compliance in European markets.

CORE COMPETENCIES

Strategic thinking, customer-first mindset, business judgment and operational discipline. Scientific and technical literacy

• able to engage credibly with scientists, engineers, and clinicians. Regulatory and quality knowledge

• IVD, GMP, UL/FDA, ISO 13485.

  Financial acumen
• P&L management, budgeting, long capital cycles, inventory management.

A collaborative style that pairs technical depth with the interpersonal skills to build teamwork in solving problems. Ability to make sound technical and people decisions under ambiguity, competing priorities and time pressures.

Job Type:

Full-time Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Language:

Mandarin (Required)

Work Location:

In person