Project Development Engineer
4 weeks ago
The Project Development Engineer Intern will support the development and management of existing and new products at Extremity Care. This role will involve product processing, testing, and marketing, as well as equipment management associated with products.
Key Responsibilities
Support the 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 a focus on repeatability and practicality in conjunction with Quality Assurance and Operations departments.
Author and 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 in the 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 the investigation of quality events and determine appropriate containment, preventive/corrective actions.
Develop a 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.
Requirements
Bachelor's degree (or current enrollment) in an Engineering, biological science, or related field.
CAD software experience preferred.
Mechanical Design experience preferred.
Ability to work in a fast-paced environment and effectively communicate complex ideas.
Strong analytical and creative thinking skills, with the ability to work independently and in a team environment.
Proficient in Microsoft Office and able to secure and maintain a favorable background investigation and clearance.
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