Drives design and development of medical devices in the regenerative medicine space addressing unmet clinical needs.
- Under general direction, the Senior Engineer will perform engineering duties associated with the design, research, development, and implementation of complex research and product development projects.
- Independently determines and develops technical strategies to inform task and deliverable planning. Work is reviewed upon completion for adequacy in meeting objectives.
- Represents the department as the technical contact/resource on assigned projects. Interacts with a variety of functions, both technical and non-technical.
- New Product Development: Typically serves as Product Development representative on cross-functional project teams within the Business Stage Gate Process; establishes technical strategies and defines tasks, deliverables, and timelines, budgets and resource needs with project sub-team and leads the execution of the established technical strategies.
- Partners with Marketing and cross-functional stakeholders to establish user requirements and then translates them into clinically relevant technical requirements through research and customer interactions
- Develops and/or applies physical and mathematical models in support of product design; develops experimental designs and protocols to demonstrate product feasibility; analyzes and resolves complex design problems associated with product performance
- Designs products, including prototype development of devices, fabrication, verification testing and analysis; applies understanding of surgical and medical procedures, products and trends in related therapeutic area to product design
- Designs novel test methods and testing fixtures and apparatus in support of technical strategies and design verification.
- Develops technical specifications (design and test, and test method development) to meet product requirements; applies advanced engineering principles to the design, fabrication, testing and evaluation of products and when resolving technical challenges
- Prepares and delivers technical and project presentations to internal and external customers, including senior management
- Identifies outside vendors and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines
- Leads technical reviews; reviews and approves the work of more junior engineers, scientists and lab associates;
- Coaches and mentors junior technical staff
- Post-Transfer/Sustaining Engineering Support:
- Serves as technical/design control expert to support Regulatory, Quality, Manufacturing, Marketing and Sales as needed
- Supports Change Control Assessments
- Audit Support & Responses
- Innovates by identifying, investigating, and evaluating existing technology; designs and implements new methodologies, materials, machines, processes or products
- Executes against the overall strategy for the Plastics and Regenerative Medicine Franchise
- Bachelors Degree in engineering or related field with 6+ years Product Development experience, or Masters degree with 4+ years Product Development experience, or PhD with 2+ years Product Development experience
- Medical device experience or experience in a regulated environment
- Experience developing products within a business stage gate process (preferred)
Significant Work Activities: N/A
Job Type: Experienced