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Manufacturing Process SME
Jin Liang brings over two decades of expertise in electronics hardware engineering, advanced materials, and manufacturing technology. He holds a Ph.D. in Materials Science & Engineering from MIT and has held senior technical roles at Philips, Dell, Vicor, and other leading organizations.
Electronic Components Management SME (Founder)
Po Tse brings over 25 years of expertise in PCBA manufacturing, electronics component engineering, and product reliability. He holds advanced degrees in Electrical Engineering, Management, and has pursued doctoral studies in Manufacturing Engineering.
Quality Assurance Engineering
With over 25 years in the medical device industry, Siu Ng is an experienced quality and engineering professional spanning the full product life cycle from R&D through sustaining engineering. He has held key roles at Johnson & Johnson, Philips Healthcare, Abbott, and Roche, and holds a B.S. in Mechanical Engineering from Worcester Polytechnic Institute.
IT Administrator
Brandyn Tse is a full-stack developer and IT professional with expertise in Java, React, and cloud infrastructure. He holds a B.S. in Information Technology and multiple industry certifications including CompTIA Security+, Network+, and AWS Cloud Practitioner.
Regulatory Affairs
Crystal Shinn is a biotech regulatory affairs leader with over 15 years of experience guiding global market access for medical devices. She specializes in FDA, EU, and international compliance for Class II/III devices, SaMD, and digital health applications. She holds RAC certification from RAPS.
Quality Systems Management
David Landis is a quality engineering professional with over 35 years of medical device and IVD experience. He has led quality teams at Philips, Werfen, and Roche, with deep expertise in FDA, EU MDR/IVDR, and ISO standards. He holds an M.S. in Biochemistry.
Manufacturing Process SME
Jin Liang is a seasoned electronics engineering expert with over two decades of experience spanning advanced materials, manufacturing technology, and reliability engineering. He holds a Ph.D. in Materials Science & Engineering from MIT.
Throughout his career, Jin has held senior technical and leadership positions at Philips, Dell/EMC, Vicor, MEMSIC, and Rockwell International. At Philips, he serves as Principal Architect and PCBA Technology Expert, driving company-wide PCB and assembly technology development for mission-critical medical systems including MRI, CT, and ultrasound devices. His work has delivered major quality improvements and significant cost savings.
Jin's expertise includes lead-free soldering and RoHS compliance, electronic packaging and flip-chip technology, reliability assessment and failure analysis, and thermal and structural modeling. He has built and managed advanced packaging labs, led cross-functional R&D initiatives, and collaborated with global suppliers and manufacturing partners to solve complex engineering challenges.
Electronic Components Management SME (Founder)
Po Tse is a highly respected veteran of the electronics industry with more than 25 years of experience spanning PCBA manufacturing, strategic purchasing, cost negotiation, product reliability, and hardware design and testing. He holds a B.S. in Electrical Engineering, an M.S. in Management, and a Ph.D. in Manufacturing Engineering (CAD).
Po brings extensive expertise in PCB technologies and electronic components, including ASICs, FPGAs, microprocessors, memory devices, and passive components. He has a strong track record in strategic supplier planning and selection and is recognized for cultivating effective cross‑functional partnerships that deliver measurable business impact. His contributions at Philips Healthcare, Nortel Networks, and Textron Defense Systems consistently focused on harmonizing best practices and driving quality and reliability improvements across organizations.
His core competencies include RoHS compliance and lead‑free reliability, Design for Reliability (DfR), and advanced PCBA manufacturing processes. In addition, Po is an accomplished trainer, providing both hands‑on and academic instruction in quality systems, reliability engineering, and lead‑free soldering methodologies. His passion for product reliability and component performance enables customers to reduce cost while achieving superior technical and operational outcomes.
Quality Assurance Engineering
Siu Ng has over 25 years of experience in the medical device field in products ranging from catheters, stents, and implants, to blood testing devices, surgical power tools, and defibrillator/monitors. His roles have spanned the complete product life cycle: research, product development, manufacturing, quality assurance/engineering, current product/sustaining engineering, and product obsolescence. These roles have taken him to some of the most recognizable names in the medical device and pharmaceutical equipment sector, such as Maquet/Getinge, Philips Healthcare, Abbott, Meridian Bioscience, Roche, and DePuy Synthes/Johnson & Johnson. Along the way, he has acquired knowledge and experience in Change Control, Audits, Risk Management, Failure Analysis, and Product Decontamination (cleaning, disinfection, sterilization) as well as Biocompatibility. He specializes in leading teams through the investigation and resolution of Corrective and Preventive Actions (CAPAs), Failure Mode and Effects Analysis (FMEA), Health Hazard Evaluation (HHE), as well as Audit Remediation activities.
Siu earned a B.S. in Mechanical Engineering with a Biomedical Concentration (MEB) from Worcester Polytechnic Institute (WPI). He also has continuing education in Lean Six Sigma (Green Belt), Project Management Certification (WPI Corp. Ed.), and Lead Auditor and Medical Device Auditing (Exemplar Global).
IT Administrator
Brandyn Tse is a full-stack developer and IT professional responsible for building and maintaining the company's web presence and technology infrastructure. He holds a B.S. in Information Technology from Western Governors University and a B.A. in English from Gordon College.
Brandyn has hands-on experience developing full-stack applications using Java, Spring Boot, React, and PostgreSQL. As a software engineer at Catalyte, he contributed to agile development teams building user portal systems, designing RESTful APIs, and maintaining high standards for testing and documentation. His IT support background includes managing Active Directory environments, troubleshooting hardware and software issues, and implementing security configurations.
Brandyn holds CompTIA A+, Network+, and Security+ certifications, along with AWS Cloud Practitioner and ITIL4 Foundations credentials. He is focused on building scalable, secure infrastructure—including the development of this website and ongoing work on self-hosted application environments.
Regulatory Affairs
Crystal Shinn is an accomplished biotech leader with over 15 years of experience providing global regulatory leadership within multinational, multibillion-dollar organizations. She is recognized for her strong leadership and communication skills, global regulatory intelligence, and deep technical and analytical problem-solving expertise.
Crystal has proven success guiding cross-functional teams through regulatory compliance initiatives and developing global strategies for Class II and Class III medical devices, Software as a Medical Device (SaMD), digital mobile applications, and interoperable systems. Her expertise spans FDA, EU MDR, Health Canada, and international regulations, with specific experience in emerging areas such as AI/ML and cybersecurity compliance.
She is proficient in preparing regulatory submissions to authorities worldwide, including the US FDA, Canada, EU, Australia, UK, and Brazil. Crystal holds a RAC Certificate in Medical Devices from the Regulatory Affairs Professional Society (RAPS).
Quality Systems Management
David Landis is a quality engineering professional with over 35 years of experience in medical device and IVD companies, supporting hardware, software, and reagent new product development. He holds an M.S. in Biochemistry from the University of Missouri and a B.S. in Food Science from the University of Illinois.
He has led quality teams across multiple sites at companies including Philips, Werfen, and Roche, driving design control and risk management excellence. His expertise spans FDA 21 CFR Part 820, EU MDR/IVDR regulations, ISO 13485, ISO 14971:2019, and MDSAP.
Drawing from experience in R&D, Operations, and Quality, David helps strengthen quality systems, solve complex issues, and prepare teams for audits—ensuring the launch of compliant, patient-focused healthcare products.
