New Product Development Engineer

Product Development Engineer will support concept-to-commercialization of a new internal feeding device(s) in the Digestive Health Business Unit. You will work with Marketing and cross functional team(s) to convert user needs into Engineering requirements and feasible solutions leading to commercialization of medical device(s). Along with participating in large projects as a SME on a sub-system, it is expected that this role will be able to also lead small NPD projects and technology development projects. Primary duties include assessing engineering requirements from user needs, component/ material(s) selection, planning product design, developing test system(s), prototyping, verification and reliability test planning and execution

Provide tactical platform level technical leadership for developing medical devices

Drive product development and design control activities from concept to commercialization via stage-gate process

Design and develops components, products, processes, fixtures, and test method development

Create engineering specifications, drawings, work instructions and technical reports

Navigate the Intellectual landscape for filings and protection

Present and discuss technical concepts, tradeoffs, analyses, cost, and performance estimates and steer the product development team with data driven decisions

Apply a working knowledge of materials and processes used in medical devices

Conduct and timely document technical design reviews

Manage new mold sampling, material samples, engineering changes, etc

Lead cooperative efforts with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success

Assist in strategizing and executing customer facing activities like voice of customer and customer centric design for assigned project

Qualifications:

Required:

BS in Mechanical, Biomedical Engineering or Plastics Engineering

Expert in Solidworks 3D modeling design

Proficient in material selection, thermoplastics and thermoset molding processes

Desired Sills/Experience

Solidworks CSWE and/or CSWP certification

Experience with Plastic or Rubber Injection Molding and extrusion, Laser Engraving, Assembly, Finishing, Machining

Expertise in statistical software like Minitab and SAS-JMP

Six Sigma Green Belt certification

Certification in engineering analysis including tolerance analysis, GD&T, FEA

Experience with assembly lines and developing process documentation

7+ years of product development experience with 3 years in a lead role

Class I and class II medical device experience is desired