Join Our Team

Key Responsibilities:

New Product Introduction (NPI) and Production Transfer

• Spearhead the transition of R&D outputs into robust, scalable production processes.
• Collaborate with R&D, Quality Assurance, and Manufacturing to ensure seamless product transfers.
• Implement Design for Manufacturing (DFM) principles to optimize product designs for production.

Production Support and Optimization

• Oversee the design, documentation, and implementation of production jigs, machinery, and processes.
• Drive lean manufacturing initiatives to enhance efficiency, reduce costs, and improve product quality.
• Develop and execute comprehensive training programs for production staff.

Quality Management and Compliance

• Ensure strict adherence to FDA regulations and maintain 510(k) clearance for the HemoScreen™ analyzer.
• Implement and oversee robust quality control systems throughout the production process.
• Lead investigations into deviations and non-conformances, ensuring thorough root cause analysis and effective corrective actions.

Engineering Change Management

• Oversee the implementation of Engineering Change Orders (ECOs) across production lines and contractors.
• Ensure changes are executed with minimal disruption to production while maintaining product quality and regulatory compliance.

Contractor Management and Supply Chain Optimization

• Qualify and manage contractors to ensure alignment with PixCell Medical’s quality standards and production goals.
• Collaborate with Supply Chain to optimize supplier relationships and component sourcing.

Continuous Improvement and Innovation

• Lead cost reduction initiatives without compromising product quality or performance.
• Drive process improvements to enhance manufacturing efficiency and product reliability.
• Collaborate with R&D to identify opportunities for product enhancements based on manufacturing insights.

Deviation and Non-Conformance Management

• Establish and oversee a robust system for identifying, reporting, and investigating deviations and non-conformances.
• Lead root cause analysis efforts for critical and major deviations, utilizing tools such as 5-Why, Fishbone Diagrams, and Pareto Analysis.
• Implement data-driven approaches to trend analysis for identifying systemic issues and opportunities for improvement.

Corrective and Preventive Action (CAPA) Management

• Develop and implement effective CAPA plans based on deviation and non-conformance investigations.
• Ensure timely closure of CAPA items and verify their effectiveness in preventing recurrence of issues.
• Foster a culture of continuous improvement and proactive problem-solving within the engineering team.

Job Requirements:

• BSc. degree in Engineering (Manufacturing, Industrial, or Biomedical preferred).
• 10+ years of senior management experience in medical device manufacturing or related industries.
• Proven expertise in NPI processes, production optimization, and quality management systems.
• Strong knowledge of FDA regulations, ISO 13485, and experience maintaining 510(k) clearance.
• Demonstrated proficiency in lean manufacturing principles, Six Sigma methodologies, and statistical process control.
• Extensive experience in managing complex engineering projects and cross-functional teams.
• Strong background in root cause analysis, CAPA implementation, and quality improvement methodologies.
• Excellent communication and leadership skills, with the ability to influence at all levels of the organization.

Key Performance Indicators

• Successful execution of NPI projects with seamless transitions from R&D to production.
• Improvement in key production metrics (e.g., yield, cycle time, cost reduction).
• Reduction in deviation and non-conformance rates through effective root cause analysis and CAPA implementation.
• Achievement of regulatory compliance standards and successful completion of audits.
• Development and execution of strategic initiatives leading to significant cost savings and efficiency improvements.

Why Join PixCell Medical?

As VP of Engineering at PixCell Medical, you will play a pivotal role in advancing our mission to revolutionize point-of-care diagnostics. You’ll lead a talented team in optimizing manufacturing processes for groundbreaking medical devices while driving innovation in healthcare. This is an opportunity to make a tangible impact on global health by ensuring the reliable production of cutting-edge diagnostic tools.

Join us in shaping the future of blood diagnostics and improving patient care worldwide!

Key Responsibilities:

• Lead system engineering activities for new product and feature development
• Define requirements and specifications for new capabilities
• Plan and execute system-level experiments, analyze data, and propose data-driven solutions
• Specify and review test procedures, validate and verify product performance
• Lead failure investigations, root-cause analyses, and preventive design improvements
• Develop and implement tools for production, quality control, and performance monitoring
• Collaborate closely with software, algorithm, mechanical, and electrical engineering teams

Job Requirements:

The ideal candidate is highly experienced in multidisciplinary product development, passionate about their work, and a strong team player. They combine technical excellence with attention to detail and the ability to deliver on time and with high quality.

• B.Sc. in Electrical Engineering / Computer Science / Physics from a recognized university (M.Sc. preferred)
• 3+ years of experience in system engineering in a multidisciplinary environment (software, algorithms, mechanics, electronics)
• Proven experience in data analysis, statistical analysis, preparing reports, and proposing
  data-driven solutions
• Hands-on experimentalist with strong troubleshooting skills
• Self-motivated and independent, with the ability to take ownership of tasks
• Open-minded engineer/scientist who is inquisitive and eager to learn
• Well-organized and capable of leading multiple complex technical tasks simultaneously
• Fluency in English (spoken and written)
• Strong interpersonal and communication skills
• High-level programming skills in MATLAB or Python (Advantage)
• Experience with medical/diagnostic equipment design, quality, and regulatory requirements (ISO 13485, IEC 60601)
• Experience with image processing, machine vision, or electro-optic systems

Key Responsibilities:

• Sales Strategy and Planning:
  Implement strategic sales plans, set sales targets, and identify opportunities for growth within the region.
• Sales Execution: Monitor and manage their sales funnel and pipeline, ensuring effective sales processes and activities are in place to meet their sales goals.
• Customer Relationship Management: Build and maintain strong relationships with key POC customers within the region, understanding their needs and addressing their concerns.
• Reporting and Forecasting:
  Strong familiarity with sales CRM systems, including HubSpot.
• Travel: 50% required within the region to meet with prospective and current customers.

Position scope: Full-time
Location: California

Job Description:

The position involves alternating shifts: morning shift from 7:00 to 16:00 and evening shift from 16:00 to 24:00.

Join us and become part of PixCell’s amazing team!