Project Engineer

3 weeks ago

San Antonio, United States RegenTx Full time

Project Engineer - Biomedical or Mechanical

Position Title:

Project Engineer - Biomedical or Mechanical Department:

Product Development Reports To:

Head of Product Development Job Type:

Full Time Shift:

Monday - Friday 08:30 AM - 05:00 PM Exempt / Non-Exempt:

Exempt 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 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: 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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