Product Innovation Engineer — Medical Devices

Origin Biologics

Las Vegas (NV)

On-site

USD 90,000 - 120,000

Full time

5 days ago
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Job summary

Origin Biologics, Inc. in Las Vegas is seeking a Product Development Engineer to design, execute, and interpret process and product development and validation studies for HCT/Ps and medical devices.

This role supports new product development, validation, technology transfers, process improvements, and optimization projects. The position operates in a regulated environment where responsibilities impact product quality and regulatory compliance.

Qualifications

  • Minimum 3+ years of experience in product development, process development, validation, commercialization, or related activities within regulated life sciences.
  • Experience working within regulated quality systems and product development lifecycle activities is required.

Responsibilities

  • Support project plans and timelines for new product development.
  • Provide technical engineering support for projects and other company functions.
  • Support project planning, including budgeting, design inputs and outputs, design verification and validation, and design transfer to production.
  • Identify and define performance requirements for allograft, medical device, and instrumentation systems.
  • Support process risk activities (FMEA) for new and existing products and processes.
  • Develop verification and validation protocols and complete design verification studies.
  • Establish acceptance criteria, perform data analysis, and generate final reports.
  • Write, review, and revise QMS documentation, including policies, procedures, and forms.
  • Support concept designs and coordinate prototype manufacture.
  • Identify, coordinate, and support engineering change requests.
  • Ensure products adhere to company and industry quality standards and regulations.
  • Support process qualification and verification activities in cleanroom environments.
  • Support training activities for production personnel.
  • Perform investigations and root cause analysis for non-conformances and implement CAPAs.
  • Perform other duties and projects critical to engineering and the organization.

Skills

Product development
Process development
Validation
Quality systems
Design verification

Education

Bachelor of Science in Engineering

Job description

Origin Biologics, Inc. in Las Vegas is seeking a Product Development Engineer to design, execute, and interpret process and product development and validation studies for HCT/Ps and medical devices.

This role supports new product development, validation, technology transfers, process improvements, and optimization projects. The position operates in a regulated environment where responsibilities impact product quality and regulatory compliance.

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