Senior Project Engineer - Medical Device

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.