Project Engineer - Biomedical - Research & Development-TAM

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: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.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 preventive/corrective actions.Support regulatory and reimbursement submissions for products.Develop and execute validation protocols in accordance with regulatory. Review validation data and draft validation reports.Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance required for assigned product development projects.Develop working knowledge of FDA, AATB, and other regulatory requirements if applicable.Perform other related duties as assigned.Report to work in-person and start job on time for established shift.Complete required hours on assigned duties works shift to complete assigned responsibilities and duties.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.Ability to secure and maintain a favorable background investigation and clearance.Education & Experience:Bachelor’s degree in biomedical or mechanical engineering or related field required.3 years of experience in project management required.Experience with Mechanical Design.Experience with CAD Software, preferably SolidWorks.Experience in medical device product development and manufacturing.Experience in FDA or AATB regulated field.

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