Tiger BioSciences LLC
Senior Project Engineer - Birth Tissue
Tiger BioSciences LLC, San Antonio, Texas, United States, 78208
Overview
Senior Project Engineer - Birth Tissue role at Tiger BioSciences LLC.
Responsibilities
Lead critical or complex product development projects from concept to market launch
Define project scope and deliverables required for new product development (NPD) and sustaining projects in alignment with cross-functional stakeholders
Lead project management activities including schedules, budgets, work products, and deliverables with project goals
Drive achievement of project timelines in support of business objectives
Define the engineering project approach and own technical project decisions within approved guardrails and alignment with business objectives, escalating items that exceed authority
Implementation of design control practices for NPD projects and completion of all phase gate deliverables
This includes collecting market feedback to identify critical product characteristics
Develop and execute validation protocols in accordance with regulatory requirements
Review results and author validation reports
Serve as engineering representative in cross-functional leadership discussions and strategic decision-making
Lead multi-disciplinary teams, driving accountability and timely delivery across functions
Mentor and provide technical guidance to Project Engineers and Associate Project Engineers on product design, manufacturing process, troubleshooting, engineering drawings, and design controls
Develop and review risk management documents such as failure modes and effects analysis (FMEA)
Proactively identify operational or engineering process gaps and lead cross-functional efforts to address them
Collaborate with the QA/RA departments on the development of supplier agreements, labeling, product claims, regulatory submissions, regulatory strategies, and sales & marketing materials
Lead cross functional and executive updates to provide project status, risks, mitigations, impacts, and achieve cross-functional alignment
Develop scalable manufacturing processes for new products in collaboration with the Research, Quality Assurance (QA), and Operations departments
Draft, revise and maintain standard operating procedures (SOPs) in accordance with FDA, AATB, and other regulations, standards
Review, analyze, and characterize critical financial characteristics of products including BOMs and COGS
Lead the design transfer of new products to the Operations department
This includes conducting group training for new products, processes, and associated equipment
Oversee and manage processing of human tissue as part of the development of new processes
Design and execute study experiments for product development projects
Complete data collection, data analysis, and reports
Execute and plan new company initiatives including product development, continuous improvement, cost reductions, and others
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 such as CAPAs and Non-conformances
Implement and identify ASTM, AAMI, ISO, or other relevant testing standards 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
Report to work in-person and start job on time for established shift
Perform other duties as assigned
Skills
Excellent technical writing skills
Capable of working independently and in a team environment
Experience working in a cleanroom manufacturing environment
Experience with validation procedures
Strong analytical and creative thinking skills
Experience working with vendors and suppliers
Excellent attention to detail and organization
Excellent written and verbal communication
Ability to multi-task and work in a fast-paced environment
Effective project management experience
Proficiency in Microsoft Office
Qualifications/Requirements
Bachelor’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field required
Master’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field preferred
5 years of product development experience required
4 years of project management experience required
Strong mechanical design and 3D modeling experience required
Manufacturing process design experience required
Tissue handling experience preferred
Working knowledge of design control processes required
Experience with HCT/Ps and/or medical devices required
Clearance of favorable background investigation required
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Responsibilities
Lead critical or complex product development projects from concept to market launch
Define project scope and deliverables required for new product development (NPD) and sustaining projects in alignment with cross-functional stakeholders
Lead project management activities including schedules, budgets, work products, and deliverables with project goals
Drive achievement of project timelines in support of business objectives
Define the engineering project approach and own technical project decisions within approved guardrails and alignment with business objectives, escalating items that exceed authority
Implementation of design control practices for NPD projects and completion of all phase gate deliverables
This includes collecting market feedback to identify critical product characteristics
Develop and execute validation protocols in accordance with regulatory requirements
Review results and author validation reports
Serve as engineering representative in cross-functional leadership discussions and strategic decision-making
Lead multi-disciplinary teams, driving accountability and timely delivery across functions
Mentor and provide technical guidance to Project Engineers and Associate Project Engineers on product design, manufacturing process, troubleshooting, engineering drawings, and design controls
Develop and review risk management documents such as failure modes and effects analysis (FMEA)
Proactively identify operational or engineering process gaps and lead cross-functional efforts to address them
Collaborate with the QA/RA departments on the development of supplier agreements, labeling, product claims, regulatory submissions, regulatory strategies, and sales & marketing materials
Lead cross functional and executive updates to provide project status, risks, mitigations, impacts, and achieve cross-functional alignment
Develop scalable manufacturing processes for new products in collaboration with the Research, Quality Assurance (QA), and Operations departments
Draft, revise and maintain standard operating procedures (SOPs) in accordance with FDA, AATB, and other regulations, standards
Review, analyze, and characterize critical financial characteristics of products including BOMs and COGS
Lead the design transfer of new products to the Operations department
This includes conducting group training for new products, processes, and associated equipment
Oversee and manage processing of human tissue as part of the development of new processes
Design and execute study experiments for product development projects
Complete data collection, data analysis, and reports
Execute and plan new company initiatives including product development, continuous improvement, cost reductions, and others
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 such as CAPAs and Non-conformances
Implement and identify ASTM, AAMI, ISO, or other relevant testing standards 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
Report to work in-person and start job on time for established shift
Perform other duties as assigned
Skills
Excellent technical writing skills
Capable of working independently and in a team environment
Experience working in a cleanroom manufacturing environment
Experience with validation procedures
Strong analytical and creative thinking skills
Experience working with vendors and suppliers
Excellent attention to detail and organization
Excellent written and verbal communication
Ability to multi-task and work in a fast-paced environment
Effective project management experience
Proficiency in Microsoft Office
Qualifications/Requirements
Bachelor’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field required
Master’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field preferred
5 years of product development experience required
4 years of project management experience required
Strong mechanical design and 3D modeling experience required
Manufacturing process design experience required
Tissue handling experience preferred
Working knowledge of design control processes required
Experience with HCT/Ps and/or medical devices required
Clearance of favorable background investigation required
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