Product Development Lead Engineer
2 weeks ago
Innovative and reputable medical device manufacturer is searching for a New Product Development Engineer who will support concept to commercialization of a new internal 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.
Essential Duties and Responsibilities:
- 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.
- Ability to read engineering prints and apply GD&T and use metrology and measuring equipment.
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.
- Ability to work with Microsoft Office (Word, Excel, PowerPoint, etc.)
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