Project Engineer - Biomedical or Mechanical

  • ExtremityCare
  • San Antonio, TX
  • Product Development
  • Full Time
  • Head of Product Development
  • Exempt
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The Project Engineer will support existing and new products with project management and development. This will include product management, prototyping, testing, and marketing associated with products.


Duties & Responsibilities:

  • Experience developing sterile products
  • Experience with CAD software (Solid works, fusion, AutoCAD)
  • Experience with the process validation and sterilization validations
  • Experience planning and drafting validation protocols and validation reports
  • Experience with the validation of sterile barrier packaging systems
  • Experience leading projects from the research phase to commercialization
  • Design and development of manufacturing procedures
  • Familiarity with ISO 13485, AATB, or risk management standards
  • Experience with design control procedures
  • Experience working in or with ISO classified cleanrooms
  • Familiarity working with ASTM, FDA and ISO standards
  • Execute new product development projects as additions to the company portfolio in conjunction with Technology, Quality Assurance, and Operations departments.
  • Collect, organize, and communicate customer and market feedback to identify critical product characteristics.
  • Assist development of manufacturing processes with focus on repeatability and practicality.
  • Revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Review, analyze, and characterize critical financial characteristics of products including COGS.
  • Assist with training and technology transfer for new products.
  • Perform processing of human tissue as part of the development of new processes.
  • Specify, order, evaluate, and onboard new proprietary equipment in support of products.
  • Lead project management activities on assigned projects including schedule, budget, work products and deliverables.
  • Follow projects from initiation to completion working with multidepartment teams.
  • Execute, and assist planning of new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support.
  • Collaborate with department teams to establish and support project timelines.
  • Organize appropriate methods of communication between project stakeholders.
  • Support and expand existing product lines by responding to business development needs, collecting, and organizing product feedback, and improving and supporting products.
  • Support the development and implementation of sales material for products and work with Quality Assurance to ensure all claims are appropriate for market and regulatory position.
  • Support existing and new products with literature review and summarization.
  • Assist with investigation of product quality events and appropriate preventive/corrective actions.
  • Support regulatory and reimbursement submissions for products.
  • Assist design and performance of validation protocols in accordance with regulatory requirements.
  • Develop working knowledge of FDA, AATB, and ISO regulatory requirements.
  • Perform other related duties as assigned.


Skills & Abilities:

  • Project Management experience.
  • Ability to present complex ideas.
  • Technical writing ability.
  • Knowledge of manufacturing environment and validation procedures.
  • Strong analytical and creative thinking skills.
  • Ability to work in a fast-paced environment.
  • Ability to work independently and in a team environment.
  • Proficient in Microsoft Office.
  • Experience working with vendors and suppliers.


Education & Experience:

  • Bachelor’s degree in biomedical or mechanical engineering or related field required.
  • 3 years of experience in project management required.
  • Education in Engineering, or Biological Science or related field preferred.
  • Product Development and exposure to medical products preferred.
  • Experience with allografts and/or medical devices preferred.

Quality Control Manager - Quality Assurance

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