Job title: Engineering Specialist III
Location: West Chester, PA
Designs and develops new implants and instrumentation and/or support in-market products through their product life-cycle within multiple cross-functional project teams. This includes communication with surgeons and sales consultants, understanding of clinical issues, defining the design parameters, and ensuring the correct product is provided to the customer. Furthermore, the Senior R&D Engineer will be an integral resource to the R&D team, as a leader and mentor for associate product development engineers and new product development engineers.
Position Duties and Responsibilities:
• Responsible for the design and development aspects of complex systems and projects, technically leading cross-functional project teams through all phases of the product life-cycle, and will often organize, plan, execute and oversee projects through product launch, commercialization, and post market surveillance.
Key responsibilities for this role include:
• Act as a technical team leader and in some cases project leader as a member of a cross-functional project core team (marketing, manufacturing, quality, testing, supply chain etc.).
• Engage surgeons to define user needs, design inputs, and new surgical techniques.
• Solve complex design problems utilizing CAD techniques, rapid and conventional prototyping and other available technologies. Generate design concepts and prototypes independently.
• Perform design evaluations (such as tolerance analysis, FEA, simulated use testing, dry labs and wet tissue labs etc.) Document clinical and surgical technique observations to create meaningful design solutions.
• Development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
• Drive initial patent review and freedom to operate activities from concept to launch.
• Collaborate with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation
• Demonstrate proficiency in the application of design controls and development processes, and support the project leader with aspects of the project management functions including scope definition, and contingency planning.
• Act as an expert on existing product lines and detailed knowledge of applicable anatomic pathologies.
• Perform complaint investigations and field investigation activities in support of patient/customer safety.
• Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
• Support Operations projects associated with Cost Improvement Projects and Production Transfers.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• This position may require up to 10% travel.
• A minimum of six years of experience in the design and development of medical devices, mechanical products, or biomechanical systems, including multi-component systems, is required.
• BS in Mechanical Engineering, Biomedical Engineering, or equivalent required. A Master’s degree is preferred.
• Strong experience with CAD software (Pro-E, Creo, Solidworks, etc.) required.
• Experience in medical device industry and knowledge of Regulatory Design Controls is highly preferred.
• Experience in identifying user needs (VOC), medical device design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required.
• Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required.
• Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel.
• Possess strong organizational skills to support all aspects of the project management functions including scope definition, budgeting, and contingency planning.
• Demonstrated creative design ability.
• Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience
• Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/ or teams, and work effectively as a technical leader and sometimes as a project leader.
• The ability to review and critically assess patents and other forms of intellectual property is preferred.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required