Associate Project Engineer - Birth Tissue

Purpose

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

Responsibilities

• Support the development of new products in collaboration with the project team, Quality Assurance and Operations departments
• Develop scalable and repeatable manufacturing processes for new products in collaboration with the Quality Assurance (QA) and Operations departments
• Author and revise standard operating procedures (SOP) according to FDA, AATB, and other regulations if applicable
• Perform processing of human tissue as part of the development of new products and processes
• Support the development and implementation of sales material for products and collaborate with QA/RA to ensure all claims are appropriate for market and regulatory position
• Design and execute scientific experiments for product development projects
• Complete data collection, evaluation, and interpretation of results to generate statistically significant data to support project decisions and/or product launch
• Experimentation may extend to in-vitro or in-vivo assays conducted in-house or externally sourced
• Communicate and negotiate with new or existing vendors to source and implement testing, equipment, supplies, materials, or other resources to support research project activities
• Assist the Operations department in the maintenance, assembly, installation, or implementation of new equipment or process specific tooling
• Design, order, evaluate, and onboard new proprietary equipment in support of manufacturing
• Assist in the maintenance/calibration of new equipment
• Assist in the development, drafting, and execution of verification and validation protocols in accordance with regulatory requirements and industry best practices
• Assist with training and technology transfer for new projects and products
• Assist in the development and maintenance of the project schedule for assigned projects
• Ensure quality and quality control within their assigned projects
• Maintain effective communication with the project team on progress and challenges related to project tasks
• 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
• Maintain effective communication with the project team on progress and challenges related to project tasks
• Report to work in-person and start job duties on time for established shift
• Complete required hours on assigned works shift to complete assigned responsibilities and duties
• 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

• Organized and self-motivated
• Excellent attention to detail
• Strong analytical and creative thinking skills
• Effective communication and technical writing skills
• Ability to present complex ideas
• Ability to work in a fast-paced environment
• Ability to work independently and in a team environment
• Competent in project management
• Proficient in Microsoft Office

Qualifications/Requirements

• Bachelor’s degree (or current enrollment) in an Engineering, or biological science or related field required
• Experience with Mechanical Design
• Experience with CAD Software
• Experience or knowledge in Project Management
• Entry Level Position
• Tissue handling experience preferred
• Clearance of favorable background investigation required