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Project Development Engineer

2 months ago

San Antonio, Texas, United States Extremity Care Full time
Job Description

Job Summary:

Extremity Care is seeking a highly motivated and detail-oriented Project Development Engineer to support the management and development of new and existing products. This role will involve product development, processing, testing, and marketing as well as equipment management associated with products.

Key Responsibilities:

  • Product Development: Collaborate with the project team, Quality Assurance, and Operations departments to develop new products.
  • Manufacturing Process Development: Develop scalable and repeatable manufacturing processes for new products in collaboration with Quality Assurance and Operations departments.
  • Standard Operating Procedures: Author and revise standard operating procedures (SOP) according to FDA, AATB, and other regulations if applicable.
  • Product Processing: Perform processing of human tissue as part of the development of new products and processes.
  • Sales Material Development: Support the development and implementation of sales material for products and collaborate with QA/RA to ensure all claims are appropriate for market and regulatory position.
  • Scientific Experimentation: Design and execute scientific experiments for product development projects. Complete data collection, evaluation, and interpretation of results to generate statistically significant data to support project decisions and/or product launch.
  • Vendor Management: Communicate and negotiate with new or existing vendors to source and implement testing, equipment, supplies, materials, or other resources to support research project activities.
  • Equipment Maintenance: Assist the Operations department in the maintenance, assembly, installation, or implementation of new equipment or process-specific tooling.
  • Proprietary Equipment: Design, order, evaluate, and onboard new proprietary equipment in support of manufacturing. Assist in the maintenance/calibration of new equipment.
  • Verification and Validation: Assist in the development, drafting, and execution of verification and validation protocols in accordance with regulatory requirements and industry best practices.
  • Training and Technology Transfer: Assist with training and technology transfer for new projects and products.
  • Project Schedule: Assist in the development and maintenance of the project schedule for assigned projects.
  • Quality Control: Ensure quality and quality control within their assigned projects.
  • Quality Events: Assist with investigation of quality events and determine appropriate containment, preventive/corrective actions.
  • Regulatory Knowledge: Develop working knowledge of FDA, AATB, and ISO regulatory requirements.
  • Communication: Maintain effective communication with the project team on progress and challenges related to project tasks.

Requirements:

  • Education: Bachelor's degree (or current enrollment) in an Engineering, or Biological science or related field required.
  • Experience: Experience with Mechanical Design, CAD Software, and Project Management.
  • Skills: Organized and self-motivated, excellent attention to detail, strong analytical and creative thinking skills, effective communication and technical writing skills, ability to present complex ideas, ability to work in a fast-paced environment, ability to work independently and in a team environment, competent in project management, and proficient in Microsoft Office.