Senior Project Engineer - Medical Device
Purpose
The Senior Project Engineer for the Medical Devices Team will be responsible for supporting existing products and the development of new products. This will include leading project management, product development, and verification & validation activities.
Responsibilities
Manage and execute product development projects from ideation to market launch and sustaining
Identify and develop project deliverables required for the launch of new products in collaboration with the Quality Assurance and Operations departments
Lead project management activities on assigned projects including the project schedule, budget, work products and deliverables
Execute projects following design control practices and develop necessary project inputs and outputs required for each development phase. This includes collecting customer and market feedback to identify critical product characteristics
Design new products and accessories using CAD software and analyze with FEA or experimental analysis where needed
Develop and execute validation protocols in accordance with regulatory requirements. Review validation data and draft validation reports
Manage and mentor Project Engineers specific to the scope of a designated project
Develop and review risk management documents such as failure modes and effects analysis (FEMA)
Collaborate with the QA/RQ departments to develop quality supplier agreements, labeling, product claims, 510K submissions, regulatory strategies, and sales & marketing materials
Provide technical expertise in varied product development projects to include providing guidance to engineers in the development of product designs, manufacturing processes, troubleshooting, and design controls
Organize effective methods of communication between project stakeholders
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 training 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 and data analysis to support project deliverables. Experimentation may extend to in-vitro or in-vivo assays
Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support
Design and develop proprietary manufacturing fixtures and equipment. Order and evaluate commercial equipment to support new or existing manufacturing processes
Assist with investigation of product quality events and corrective and preventative (CAPA) actions
Support regulatory and reimbursement submissions for products
Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance 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
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
Ability to work independently and in a team environment
Project management experience
Ability to present complex ideas
Knowledge of manufacturing environment and validation procedures
Strong design skills and experience using CAD
Knowledge and experience with effective DFM reviews
Strong analytical and creative thinking skills
Experience working with vendors and suppliers
Excellent attention to detail and organization
Excellent written and verbal communication
Highest level of ethics and integrity
Ability to lead and motivate right behaviors
Ability to multi-task and work in a fast-paced environment
Strong technical writing
Effective project management
Proficiency in Microsoft Office
Qualifications/Requirements
Bachelor's degree in biomedical engineering, tissue engineering, mechanical engineering, or related field, from an accredited college or university required.
5-6 years of experience in product development required
4 years of experience in project management required
Experience in mechanical design and 3D modeling CAD software required
Experience in manufacturing process design
Working knowledge of design control processes
Experience with allografts and/or medical devices preferred.
Clearance of favorable background investigation required.
Senior Project Engineer - Medical Device
Extremity Care
San Antonio, TX
Full Time
Bachelor's
Published on 08/06/2025
Want new jobs emailed to you?
Subscribe to Job Alerts
Purpose
The Senior Project Engineer for the Medical Devices Team will be responsible for supporting existing products and the development of new products. This will include leading project management, product development, and verification & validation activities.
Responsibilities
Manage and execute product development projects from ideation to market launch and sustaining
Identify and develop project deliverables required for the launch of new products in collaboration with the Quality Assurance and Operations departments
Lead project management activities on assigned projects including the project schedule, budget, work products and deliverables
Execute projects following design control practices and develop necessary project inputs and outputs required for each development phase. This includes collecting customer and market feedback to identify critical product characteristics
Design new products and accessories using CAD software and analyze with FEA or experimental analysis where needed
Develop and execute validation protocols in accordance with regulatory requirements. Review validation data and draft validation reports
Manage and mentor Project Engineers specific to the scope of a designated project
Develop and review risk management documents such as failure modes and effects analysis (FEMA)
Collaborate with the QA/RQ departments to develop quality supplier agreements, labeling, product claims, 510K submissions, regulatory strategies, and sales & marketing materials
Provide technical expertise in varied product development projects to include providing guidance to engineers in the development of product designs, manufacturing processes, troubleshooting, and design controls
Organize effective methods of communication between project stakeholders
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 training 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 and data analysis to support project deliverables. Experimentation may extend to in-vitro or in-vivo assays
Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support
Design and develop proprietary manufacturing fixtures and equipment. Order and evaluate commercial equipment to support new or existing manufacturing processes
Assist with investigation of product quality events and corrective and preventative (CAPA) actions
Support regulatory and reimbursement submissions for products
Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance 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
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
Ability to work independently and in a team environment
Project management experience
Ability to present complex ideas
Knowledge of manufacturing environment and validation procedures
Strong design skills and experience using CAD
Knowledge and experience with effective DFM reviews
Strong analytical and creative thinking skills
Experience working with vendors and suppliers
Excellent attention to detail and organization
Excellent written and verbal communication
Highest level of ethics and integrity
Ability to lead and motivate right behaviors
Ability to multi-task and work in a fast-paced environment
Strong technical writing
Effective project management
Proficiency in Microsoft Office
Qualifications/Requirements
Bachelor's degree in biomedical engineering, tissue engineering, mechanical engineering, or related field, from an accredited college or university required.
5-6 years of experience in product development required
4 years of experience in project management required
Experience in mechanical design and 3D modeling CAD software required
Experience in manufacturing process design
Working knowledge of design control processes
Experience with allografts and/or medical devices preferred.
Clearance of favorable background investigation required.
Senior Project Engineer - Medical Device
Extremity Care
San Antonio, TX
Full Time
Bachelor's
Published on 08/06/2025
Want new jobs emailed to you?
Subscribe to Job Alerts
Job ID: 488982077
Originally Posted on: 8/11/2025
Want to find more Chemistry opportunities?
Check out the 15,634 verified Chemistry jobs on iHireChemists
Sign Up for Job Alerts
