The KYDA Partners team is searching for both Junior and Senior Project Engineers in San Antonio.
Role Overview: As a Project Engineer, you will be instrumental in managing and developing products from inception through commercialization. Your responsibilities will span product management, prototyping, testing, and marketing. You will collaborate with cross-functional teams, including Technology, Quality Assurance, and Operations, to drive innovation and ensure product excellence.
Key Responsibilities:
Product Development: Design, develop, and validate sterile products, including sterile barrier packaging systems. Lead projects from research to commercialization and oversee manufacturing procedures.
Technical Skills: Utilize CAD software (SolidWorks, Fusion, AutoCAD) for design and development. Plan and draft validation protocols and reports, ensuring compliance with ISO 13485, AATB, and relevant standards.
Project Management: Manage project timelines, budgets, and deliverables. Coordinate with multi-department teams to execute new initiatives and support product portfolio expansion.
Regulatory Compliance: Ensure adherence to FDA, AATB, and other regulatory requirements. Support regulatory submissions and assist with validation protocol development.
Customer and Market Feedback: Collect and analyze feedback to identify critical product characteristics and enhance product performance.
Process Improvement: Develop manufacturing processes with a focus on repeatability and practicality. Revise procedures to meet regulatory standards and support technology transfer for new products.
Equipment and Training: Specify, order, and evaluate new equipment. Lead training and onboarding efforts for new technologies.
Product Support: Support existing and new products through literature reviews, quality investigations, and development of sales materials.
Qualifications:
Education: Bachelor's degree in Biomedical or Mechanical Engineering, or a related field.
Experience: Minimum of 3 years in project management, with a background in product development and medical products preferred. Experience with allografts and/or medical devices is a plus.
Skills: Proficiency in CAD software, experience with validation protocols, and familiarity with ISO, ASTM, and FDA standards.