Tiger BioSciences LLC
Senior Project Engineer - Tissue
Tiger BioSciences LLC - San Antonio, Texas, United States, 78208
Work at Tiger BioSciences LLC
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Overview
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Senior Project Engineer - Tissue
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Tiger BioSciences LLC 16 hours ago Be among the first 25 applicants Join to apply for the
Senior Project Engineer - Tissue
role at
Tiger BioSciences LLC Purpose
The Senior Project Engineer 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. 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 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. Develop and execute validation protocols in accordance with regulatory Review validation data and draft validation reports. 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. Manage and execute product development projects from ideation to market launch. 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 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. Develop and execute validation protocols in accordance with regulatory Review validation data and draft validation reports. 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. Strong 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.
Qualifications/Requirements
Bachelor’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field, from an accredited college or university required. At least 5-6 years of experience in product development, or a related field, required. 4 years of experience in project management required. Experience in mechanical design and 3D modeling CAD Software. 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.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Referrals increase your chances of interviewing at Tiger BioSciences LLC by 2x Sign in to set job alerts for “Senior Project Engineer” roles.
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Senior Project Engineer - Tissue
role at
Tiger BioSciences LLC 16 hours ago Be among the first 25 applicants Join to apply for the
Senior Project Engineer - Tissue
role at
Tiger BioSciences LLC Purpose
The Senior Project Engineer 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. 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 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. Develop and execute validation protocols in accordance with regulatory Review validation data and draft validation reports. 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. Manage and execute product development projects from ideation to market launch. 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 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. Develop and execute validation protocols in accordance with regulatory Review validation data and draft validation reports. 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. Strong 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.
Qualifications/Requirements
Bachelor’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field, from an accredited college or university required. At least 5-6 years of experience in product development, or a related field, required. 4 years of experience in project management required. Experience in mechanical design and 3D modeling CAD Software. 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.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Referrals increase your chances of interviewing at Tiger BioSciences LLC by 2x Sign in to set job alerts for “Senior Project Engineer” roles.
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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