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. 

Duties & Responsibilities: 

• Execute new product development projects as additions to the company portfolio in conjunction with Technology, Quality Assurance, and Operations departments.
  • Collect, organize, and communicate customer and market feedback to identify critical product characteristics. 
  • Assist development of manufacturing processes with focus on repeatability and practicality.
  • Revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Review, analyze, and characterize critical financial characteristics of products including COGS.
  • Assist with training and technology transfer for new products. 
  • Perform processing of human tissue as part of the development of new processes. 
  • Specify, order, evaluate, and onboard new proprietary equipment in support of products.
• Lead project management activities on assigned projects including schedule, budget, work products and deliverables.
• Follow projects from initiation to completion working with multidepartment teams. 
  • Execute, and assist planning of new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support. 
  • Collaborate with department teams to establish and support project timelines. 
  • Organize appropriate methods of communication between project stakeholders.
• 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.
  • Support existing and new products with literature review and summarization.
  • Assist with investigation of product quality events and appropriate preventive/corrective actions.
  • Support regulatory and reimbursement submissions for products. 
• Assist design and performance of validation protocols in accordance with regulatory requirements.
• Develop working knowledge of FDA, AATB, and ISO regulatory requirements.
• Perform other related duties as assigned. 

Skills & Abilities: 

• 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. 

Education & Experience: 

• Bachelor’s degree in related field and education in Project Management required. 
• Education in Engineering, or Biological Science or related field preferred. 
• Minimum 12 months experience in managing project(s) from start to finish required. 
• Product Development and exposure to medical products preferred. 
• Experience with allografts and/or medical devices preferred.