Senior Project Engineer - Tissue

ZipRecruiter; San Antonio (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

A leading company in the biomedical sector is seeking a Senior Project Engineer to support the development of innovative products. This role requires overseeing product development projects from inception to launch, ensuring compliance with FDA regulations and collaboration with cross-functional teams. Ideal candidates will have a strong background in engineering, project management experience, and the ability to thrive in a fast-paced environment.

Qualifications

• At least 5-6 years of experience in product development or related field required.
• 4 years of experience in project management required.
• Experience in mechanical design and manufacturing process design.

Responsibilities

• Manage and execute product development projects from ideation to market launch.
• Develop and execute validation protocols in accordance with regulatory requirements.
• Maintain a working knowledge of FDA regulations and internal policies.

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

Education

Bachelors degree in biomedical engineering, tissue engineering, mechanical engineering, or related field

Tools

3D modeling CAD Software

Microsoft Office

Job description

Job DescriptionJob DescriptionSalary:

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

• Bachelors 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 .
• Clearance of favorable background investigation required.