Design & Process Validation Engineer Job at Stark Pharma Solutions Inc, New Jersey

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  • Stark Pharma Solutions Inc
  • New Jersey

Job Description

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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