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Process Development Engineer (Medical Device Industry)

Process Development Engineer (Medical Device Industry)

ProQualityNetworkDorado, PR, US
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Job Description

Job Description

Title : Process Development Engineer

Location : North of Puerto Rico (Open for Puerto Rico residents that are U.S. Citizens)

Employment Type : [Contract / Full-time / Onsite

Summary

Our client is seeking a Process Development Engineer to provide technical leadership in the design, validation, and implementation of new manufacturing processes and automation systems. The ideal candidate will be responsible for process development, validation, risk assessment, and cross-functional collaboration to support efficient and compliant manufacturing operations. This position offers the opportunity to contribute to innovative process solutions that enhance product quality, efficiency, and reliability.

Key Responsibilities

Process Validation

  • Support process and / or equipment validation activities, including IQ, OQ, PQ, and process performance qualification for new products or processes.
  • Develop and review Master Validation Plans, validation protocols, and final reports.
  • Collaborate with cross-functional teams to ensure validation activities meet compliance and quality standards.
  • Assist the Process Development team in qualifying new processes, establishing statistical sampling plans, and developing related procedures.
  • Design and implement in-process and receiving inspection systems for new components and processes.
  • Generate equipment documentation, such as entries, evaluations, preventive maintenance (PM), and calibration procedures.
  • Define gages, tools, and equipment required for test method development.
  • Develop manufacturing instructions and documentation for newly developed processes.
  • Work cross-functionally with other departments to achieve process development milestones.

Process Development

  • Manage process development projects from concept through implementation, ensuring project timelines and deliverables are met.
  • Demonstrate familiarity with a wide range of manufacturing technologies and equipment, including Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, and automated systems (PLC, servos, pneumatics, sensors, etc.).
  • Apply Design of Experiments (DOE) methodology to characterize and optimize processes an d analyze data for process improvement.
  • Identify and implement process improvement strategies to enhance efficiency, product quality, and yield.
  • Evaluate and mitigate risks associated with manufacturing processes using PFMEA and other risk analysis tools.
  • Collaborate with engineers, scientists, and production personnel to develop and refine manufacturing processes.
  • Communicate technical concepts clearly to technical and non-technical audiences through reports, presentations, and other communication media.

    • Quality System Responsibilities

  • Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all applicable quality procedures.
  • Ensure adequate resources (personnel, tools, and systems) are available to maintain Quality System compliance and adherence to organizational policies.
  • Promote a work environment that supports continuous quality improvement and compliance with regulatory and company standards.

    • Qualifications

  • Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field).
  • Experience in process development, validation, or manufacturing engineering within a regulated industry preferred.
  • Knowledge of process validation principles, DOE, PFMEA, and statistical methods.
  • Strong analytical, problem-solving, and technical writing skills.
  • Ability to work effectively in a cross-functional, fast-paced environment.

    • Join Our Client’s Team

    This is an excellent opportunity to contribute to innovative process technologies that enhance manufacturing quality and efficiency. If you are passionate about process development and continuous improvement, apply through the job link provided with your updated resume to be considered for this exciting opportunity.

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    Engineer Medical Device • Dorado, PR, US

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