Product Development Engineer

Product Development EngineerThe Product Development Engineer (PDE) is actively engaged in executing the main elements of New Product Realization to introduce to market novel surgery-ready surgical instruments. As a team member in this role, you will participate with the following activities: Concept Development, Design & Development, Performance Evaluation, Design Verification & Validation, and Design Transfer. This role includes both hands-on activities and planning, with a focus on innovation, execution, and efficiency.To support development of successful products, you will partner with Marketing / Sales to understand the User Needs and define Design Input. These can be obtained during Voice of Customer meetings and cadaveric / Sawbones labs. During the initial concept development, you will review the Intellectual Property landscape and determine new IP that should be filed. During this phase, prototypes are made and evaluated to assess feasibility and functionality of various design and material. As the project evolves and the product design is refined, you will create engineering drawings with close input from Manufacturing and Quality to obtain feedback on DFM and Inspection methodology. You will participate with the team to ensure relevant CTQ's are selected based on features critical to product functionality. You will work closely with Manufacturing Engineering to assist in the development of the assembly line. If required, you will oversee the development of packaging solutions once the product design is finalized.As the product design is frozen, you will participate in the execution of Design Verification & Validation activities. You will be responsible to author Test Protocols, participate in activities including product & packaging performance evaluation, perform data analysis, and write Test Reports.Principal Responsibilities and Duties:Create concept for surgical instruments, optimize and iterate the design by evaluating prototypes, and carry the optimal design through the development process to commercialization.Perform performance characterization testing using mechanical test systems (e.g. Instron).Develop and optimize electromechanical test systems.Create various elements of the Design History File and Technical File, using Design Control.Participate in the following Design Control activities: Design and Development Plan, Design Input, Design Output (e.g. engineering drawings, specifications, labels, packaging), Design Verification and Validation (e.g. write protocol, perform testing, write test report, write engineering rationale), and Design Transfer.Participate in Design Review and Phase Review.Resolve technical challenges pragmatically and efficiently.Perform Finite Element Analysis and Mold Flow Analysis.Participate in VOC meeting, cadaver lab, and Design Validation lab with surgeons, nurses, and clinicians.Assess existing Intellectual Property and file new patents.Partner with cross-functional Core Team Members to participate in the project through completion; perform project management tasks for the activities within your responsibilities.Evaluate new technologies, tools, and processes.Qualifications - Must Have:Bachelor's degree in Mechanical Engineering or Biomedical Engineering.Minimum of 3 years of industry experience or Master's degree in relevant field.Direct experience participating in New Product Development or Research & Development of medical device.Solid experience in CAD 3D modeling, creation of Engineering Drawing (e.g. SolidWorks) and DFM.Applied knowledge and experience utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5.Experienced with Design Control and Risk Management per 21 CFR Part 820, ISO 13485, ISO 14971.Knowledge and understanding of Orthopedic procedures, instrumentation, and common implant.Experience and understanding of Design Input, Design Output, and Design V&V strategy.Experience and understanding of risk documentation such as dFMEA, pFMEA, and Risk Analysis.Strong technical writing skills and experience writing product requirements, test protocols, and test reports.Experience designing components for machining and good understanding of standard machining techniques.Good understanding of material sciences; polymer and metal selection based on the application.Project Management experience.Excellent problem-solving skills.Qualifications - Nice to Have:Experience designing components for injection molding.Experience with mechanical test equipment (e.g. Instron, MTS).Knowledge of ISO 10993 for Biological Evaluation and ISO 11737 for Sterilization.Work Environment:While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is occasionally exposed to a variety of varying weather conditions, trash, waste, chemicals and other materials. The noise level in the work environment and facility grounds can be loud.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day. The employee must lift or move items over 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Employee may need to work at a computer for several hours at a time, analyzing data and/or using software programs to create reports, metrics and/or data collection.Benefits:401(k)401(k) matchingDental insuranceEmployee assistance programEmployee discountFlexible spending accountHealth insuranceHealth savings accountLife insurancePaid time offParental leaveReferral programRetirement planVision insuranceWork Location: In person