PCB Design & testing Engineer

Vdart - Boston, MA

Full-time - Mid Level

Boston, MA

1,001-5,000 employees

Professional, Scientific, and Technical Services

About the position

The PCB Design & Testing Engineer role involves end-to-end electrical design and quality assurance within the medical device sector. The engineer will focus on PCB design, compliance with industry standards, and ensuring product quality through various engineering processes.

Responsibilities

• Develop and test PCB designs (Analog, Digital, and Mixed Signal), from schematics to layout file generation, ensuring alignment with design specifications.
• Manage component engineering processes, including selection and validation of electrical and electronic components.
• Conduct root cause analysis and execute Failure Mode and Effects Analysis (FMEA) to assess and mitigate design risks.
• Support Corrective and Preventive Actions (CAPA) and Non-Conformance (NCs) processes, ensuring timely issue resolution and compliance with quality standards.
• Apply knowledge of Medical Hardware Development Life Cycle (HDLC), including requirement traceability matrix preparation and verification.
• Lead validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validations.
• Review and approve key quality records, ensuring alignment with Quality Agreements (QA) and Quality System Execution Plans (QSEP).
• Conduct risk assessments per ISO 14971 and manage UFMEA, PFMEA, DFMEA, and SFMEA processes for product safety and efficacy.
• Prepare and manage Design Transfer Inspection Requirements (DTIR) based on risk file assessments and design requirements.

Requirements

• Bachelor's degree in Electrical Engineering.
• Proven experience in PCB Design and Testing for Analog, Digital, and Mixed Signal boards.
• Familiarity with medical device quality systems and requirements, including ISO 14971 risk management.
• Proficiency in FMEA processes, CAPA, non-conformance handling, and root cause analysis.
• Knowledge of Electrical and Electronics Components and Process Verification Engineering (PVE).
• Understanding of IQ/OQ/PQ and test method validations.
• Experience with Computer System Validation and Medical Hardware Development Life Cycle is an advantage.

Nice-to-haves

• Strong organizational and detail-oriented approach to quality and compliance tasks.
• Ability to collaborate with cross-functional teams to support quality and engineering activities.
• Excellent communication and documentation skills.

Benefits

• Long-term contract opportunity
• Work in a dynamic and diverse environment
• Opportunity to work with Fortune 500 companies