Position Title: Design & Process Validation Engineer
Location: New Jersey
Experience: 6+ years
Position Summary:
The Design & Process Validation Engineer will support new product development for surgical instruments, working as part of a cross-functional quality team. This role focuses on ensuring product quality through design verification, risk management, and process validation while driving continuous improvement initiatives.
Key Responsibilities:
Actively participate in the product development cycle by reviewing mechanical and electromechanical project documentation.
Support design verification and validation activities, including developing testing requirements in collaboration with Product Development.
Assess overall product risk by facilitating the creation of risk management tools, such as risk management plans, hazard identification, risk analysis charts, and complaint analyses.
Collect, analyze, and interpret statistical data and provide reports to management as required.
Contribute to Design and Process Validation initiatives by planning/reviewing validation and qualification activities. This may include oversight of System/Sub-system Requirements, Critical to Quality (CTQ) Matrices, Process Flows, Control Plans, Measurement Systems Analyses (MSA), and Process Capability Analyses (Cpk).
Assist with projects to ensure proper and consistent implementation of quality engineering tools.
Provide solutions to complex challenges independently, ensuring solutions are practical, thorough, and aligned with organizational objectives.
Required Skills & Qualifications:
4+ years of Quality Engineering experience in a regulated environment.
Bachelor's degree in Engineering or a related field.
Expertise in risk management, including Hazard Analysis, DFMEA, and UFMEA.
Strong experience in design verification authoring and execution.
General NPD Quality Engineering skillset (change control, CAPA, understanding of ISO 13485).
Understanding of mechanical and electromechanical design, design verification, design validation, process validation, and complaint analysis.
Preferred / Nice to Have:
ASQ Certified Quality Engineer (CQE).
Experience in medical device development and manufacturing in accordance with QSR, ISO 13485, ISO 14971, and IEC 60601 standards.
Familiarity with software and hardware interfaces.
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