Project Engineer - Tissue

Purpose

The Project Engineer will support existing and new products with project management and development. This will include product management, prototyping, testing, and marketing associated with products.

Responsibilities

• Manage and execute product development projects from ideation to market launch
• Lead project management activities on assigned projects including schedule, budget, work products and deliverable
• Execute projects following design control practices and developing the necessary project inputs and outputs required for each development phase
• Organize appropriate methods of communication between project stakeholders
• Collect, organize, and communicate customer and market feedback to identify critical product characteristics
• 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
• Review, analyze, and characterize critical financial characteristics of products including COGS
• Conduct group trainings for new processes and complete technology transfer of new products
• Perform processing of human tissue as part of the development of new processes
• 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
• Specify, order, evaluate, and onboard new proprietary equipment in support of products
• Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support
• Design and develop custom manufacturing equipment if applicable
• Support and expand existing product lines by responding to business development needs, collecting, and organizing product feedback, and improving and supporting products
• Support the development and implementation of sales material for products and work with Quality Assurance to ensure all claims are appropriate for market and regulatory position
• Conduct literature reviews to support new and existing products
• Assist with investigation of product quality events and appropriate preventive/corrective actions
• Support regulatory and reimbursement submissions for products
• Develop and execute validation protocols in accordance with regulatory requirements. Review validation data and draft validation reports
• Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance’s required for assigned product development projects
• 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
• Perform other duties as assigned
• 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
• Complete required hours on assigned duties works shift to complete assigned responsibilities and duties

Skills

• Project Management experience
• Ability to present complex ideas
• 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

Qualifications/Requirements

• Bachelor’s degree in biomedical or mechanical engineering or related field required
• 3 years of experience in project management required
• Experience with Mechanical Design
• Experience with CAD Software
• Education in Engineering, or Biological Science or related field preferred
• Product Development and exposure to medical products preferred
• Experience with allografts and/or medical devices preferred
• Clearance of favorable background investigation required