The Senior New Product Development Engineer 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 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.
The Senior New Product Development Engineer will be 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 lead projects through product launch, commercialization, and post market surveillance.
• 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, Finite Element Analysis (FEA), simulated use testing, dry labs and wet tissue labs etc.)
• Document clinical and surgical technique observations to build meaningful design solutions.
• Develop and execute design verification and validation plans and activities.
• 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 authority 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.
• Perform other special projects and functions as assigned.
• 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.
• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or relevant field required.
• A Master's degree is preferred.
• A minimum of 5 years of experience in the design and development of medical devices, mechanical products, or biomechanical systems, including multi-component systems, is required.
• Strong experience with CAD software (Pro-E, Creo, Solidworks, etc.) required.
• 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 is required.
• Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel required.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required.
• Ability to travel up to 10% required.
• Willingness to work with cadavers and within an Operating Room setting is required.
• Possess strong organizational skills to support all aspects of project management functions including scope definition, budgeting, and contingency planning required.
• Proven creative design ability required.
• Demonstrated experience & follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience required.
• Ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams required.
• Experience in medical device industry and knowledge of Regulatory Design Controls is preferred.
• Ability to work effectively as a technical leader and sometimes as a project leader preferred.
• Ability to review and critically assess patents and other forms of intellectual property is preferred.