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

Salary : $72,720