Project Engineer Intern

Purpose:

The Project Engineer Intern will support existing and new products with development and management. This will include product processing, testing, and marketing as well as equipment management associated with products.

Duties & Responsibilities:

• Support development of new products as additions to the company portfolio in conjunction with Technology, Quality Assurance, and Operations departments.
• Develop manufacturing processes of new products with focus on repeatability and practicality in conjunction with Quality Assurance and Operations departments.
• Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
• Perform processing of human tissue as part of the development of new processes.
• Support the development and implementation of sales material for products and work with Quality to ensure all claims are appropriate for market and regulatory position.
• Assist in the readiness of the company’s existing products including facility, equipment, and process specific tools.
• Design, order, evaluate, and onboard new proprietary equipment in support of manufacturing. Assist in equipment and supply onboarding and maintenance/calibration!
• Assist design and performance of validation protocols in accordance with regulatory requirements and industry best practices.
• Assist with training and technology transfer for new projects and products.
• Assist with investigation of quality events and determine appropriate containment, preventive/corrective actions.
• Develop working knowledge of FDA, AATB, and ISO regulatory requirements.
• Assist in the development and maintenance of project schedules and execution of assigned task items.
• Assist with the execution of associated project validations (process validation, sterilization validation, packaging validations, etc.)
• Assist with the design of product labels to support distribution and product launches in accordance with regulatory requirements.
• Perform other related duties as assigned.
• Starting job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments.

 Skills & Abilities:

• Organized and self-motivated. 
• Excellent attention to detail.
• Strong Analytical and creative thinking skills.
• Ability to work in a fast-paced environment.
• Ability to work independently and in a team environment.
• Effective communication and ability to present complex ideas.
• Technical writing skills.
• Project Management skills.
• Proficient in Microsoft Office.
• Ability to secure and maintain a favorable background investigation and clearance.

Education & Experience:

• Bachelor’s degree (or current enrollment) in an Engineering, or biological science or related field
• CAD software experience preferred.
• Mechanical Design experience preferred.
• Entry Level Position