Project Engineer - Biomedical

Extremity Care - San Antonio, TX

Full-time

San Antonio, TX

Miscellaneous Manufacturing

About the position

The Project Engineer will play a crucial role in supporting both existing and new products through effective project management and development strategies. This position encompasses a wide range of responsibilities, including product management, prototyping, testing, and marketing activities associated with various products. The Project Engineer will be tasked with managing and executing product development projects from the initial ideation phase all the way to market launch. This involves leading project management activities for assigned projects, which includes overseeing schedules, budgets, work products, and deliverables. The role requires adherence to design control practices, ensuring that all necessary project inputs and outputs are developed for each phase of product development. Effective communication is key in this role, as the Project Engineer will need to organize appropriate methods of communication between project stakeholders. Gathering, organizing, and communicating customer and market feedback is essential to identify critical product needs and enhancements. Additionally, the Project Engineer will collaborate with the Quality Assurance (QA) and Operations departments to develop scalable and repeatable manufacturing processes for new products. This includes authoring and revising standard operating procedures (SOPs) in compliance with FDA, AATB, and other relevant regulations. The Project Engineer will also be responsible for reviewing and analyzing the financial characteristics of products, including cost of goods sold (COGS). Conducting group training sessions for new processes and completing technology transfers for new products are also part of the job. The role involves designing and executing scientific experiments for product development projects, as well as collecting, evaluating, and interpreting data to generate statistically significant results that support project decisions and product launches. Furthermore, the Project Engineer will specify, order, evaluate, and onboard new proprietary equipment to support product development initiatives. This position also entails planning and executing new company initiatives, including equipment onboarding, supply chain management, and product support. In some cases, the Project Engineer may need to design and develop custom manufacturing equipment. Supporting and expanding existing product lines is another critical aspect of this role, which includes responding to business development needs, collecting and organizing product feedback, and improving product offerings. The Project Engineer will assist in the development and implementation of sales materials for products, ensuring that all claims are appropriate for market and regulatory positions. Conducting literature reviews to support both new and existing products, investigating product quality events, and implementing appropriate preventive and corrective actions are also part of the responsibilities. The Project Engineer will support regulatory and reimbursement submissions for products and develop and execute validation protocols in accordance with regulatory standards. This role requires a thorough understanding of ASTM, AAMI, ISO, and other necessary validation or testing guidelines, as well as FDA, AATB, and other regulatory requirements. The Project Engineer will also be expected to perform other related duties as assigned, report to work in-person, and adhere to established shift times to complete assigned responsibilities.

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 needs.
• 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 standards.
• 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.
• Develop working knowledge of FDA, AATB, and other regulatory requirements if applicable.

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.
• Experience with CAD Software, preferably SolidWorks.
• Experience in medical device product development and manufacturing.
• Experience in FDA or AATB regulated field.
• Knowledge of Design Control procedures.
• 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.
• Ability to secure and maintain a favorable background investigation and clearance.