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    Project Engineer - San Antonio, United States - Extremity Care

    Extremity Care
    Extremity Care San Antonio, United States

    1 day ago

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    Description

    Job Description

    Job DescriptionSalary: $70, $90,000.00 per year

    Purpose:

    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.

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