Purpose

The Senior Project Engineer for the Medical Devices Team will be responsible for supporting existing products and the development of new products. This will include leading project management, product development, and verification & validation activities.

Responsibilities

• 
  Manage and execute product development projects from ideation to market launch and sustaining
• 
  Identify and develop project deliverables required for the launch of new products in collaboration with the Quality Assurance and Operations departments
• 
  Lead project management activities on assigned projects including the project schedule, budget, work products and deliverables
• 
  Execute projects following design control practices and develop necessary project inputs and outputs required for each development phase. This includes collecting customer and market feedback to identify critical product characteristics
• Design new products and accessories using CAD software and analyze with FEA or experimental analysis where needed
• 
  Develop and execute validation protocols in accordance with regulatory requirements. Review validation data and draft validation reports
• Manage and mentor Project Engineers specific to the scope of a designated project
• Develop and review risk management documents such as failure modes and effects analysis (FEMA)
• Collaborate with the QA/RQ departments to develop quality supplier agreements, labeling, product claims, 510K submissions, regulatory strategies, and sales & marketing materials
• Provide technical expertise in varied product development projects to include providing guidance to engineers in the development of product designs, manufacturing processes, troubleshooting, and design controls
• Organize effective methods of communication between project stakeholders
• 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 training 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 and data analysis to support project deliverables. Experimentation may extend to in-vitro or in-vivo assays
• Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support
• Design and develop proprietary manufacturing fixtures and equipment. Order and evaluate commercial equipment to support new or existing manufacturing processes
• Assist with investigation of product quality events and corrective and preventative (CAPA) actions
• Support regulatory and reimbursement submissions for products
• Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance 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
• 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

• 
  Ability to work independently and in a team environment
• Project management experience
• Ability to present complex ideas
• Knowledge of manufacturing environment and validation procedures
• Strong design skills and experience using CAD
• Knowledge and experience with effective DFM reviews
• Strong analytical and creative thinking skills
• Experience working with vendors and suppliers
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Highest level of ethics and integrity
• Ability to lead and motivate right behaviors
• Ability to multi-task and work in a fast-paced environment
• Strong technical writing
• Effective project management
• 
  Proficiency in Microsoft Office

Qualifications/Requirements

• 
  Bachelors degree in biomedical engineering, tissue engineering, mechanical engineering, or related field, from an accredited college or university required.
• 5-6 years of experience in product development required
• 
  4 years of experience in project management required
• 
  Experience in mechanical design and 3D modeling CAD software required
• 
  Experience in manufacturing process design
• 
  Working knowledge of design control processes
• 
  Experience with allografts and/or medical devices preferred.
• 
  Clearance of favorable background investigation required.