Project Engineer - Adipose Tissue

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. Responsibilities Manage and execute product development projects from ideation to market launch Lead project management activities on assigned projects including schedule, budget, work products and deliverables Execute projects following design control practices and developing the necessary project inputs and outputs required for each development phase Organize appropriate methods of communication between project stakeholders Collect, organize, and communicate customer and market feedback to identify critical product characteristics Develop scalable and repeatable manufacturing processes for new products in collaboration with the Quality Assurance (QA) and Operations departments Author and revise standard operating procedures (SOP) according to FDA, AATB, and other regulations if applicable Review, analyze, and characterize critical financial characteristics of products including COGS Conduct group trainings for new processes and complete technology transfer of new products Perform processing of human tissue as part of the development of new processes 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 Specify, order, evaluate, and onboard new proprietary equipment in support of products Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support Design and develop custom manufacturing equipment if applicable 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 Conduct literature reviews to support new and existing products Assist with investigation of product quality events and appropriate preventative/corrective actions Support regulatory and reimbursement submissions for products Develop and execute validation protocols in accordance with regulatory requirements. Review validation data and draft validation reports Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance's required for assigned product development projects Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures Travel domestically up to 5% to attend offsite meetings, conferences, and support business initiatives Maintain acceptable attendance and punctuality for scheduled work hours and meetings Ensure completion of assigned tasks and responsibilities within defined timeframes Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice, to support business/operational needs when necessary Perform other duties as assigned Skills 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 Qualifications/Requirements Bachelor's degree in biomedical or mechanical engineering or related field required 3 years of experience in project management required Experience with Mechanical Design preferred Experience with CAD Software preferred 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 Clearance of favorable background investigation required We are an equal opportunities employer and welcome applications from all qualified candidates.

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