- Technical leadership role on project to execute product development deliverables from concept to product commercialization.
- Leadership position that may include managing, developing and mentoring other engineers and technicians.
- Lead the development, modification, implementation and supporting of Infusion disposable products through adherence to established design control processes and good engineering practices. Lead others to solve technical problems using engineering and statistical techniques. Interfaces with customers and suppliers on high-volume disposable medical device design.
- Makes design changes to existing products, ensuring compatibility through appropriate testing. Provides engineering and technical support to production with respect to product specifications and requirements. Guides the successful completion of major programs or projects.
- Concept Design: Lead product development from concepts through various stages of prototyping to final design by applying sound and good engineering principles including product requirements, concept design and selection, prototyping, testing, etc.
- Design for Manufacturability: Design and develop high-precision plastic injection molded components for high-volume production. Apply DFSS, DFA, DFR and other fundamental engineering practices. Design complex components and assemblies capable of achieving overall device requirements. Perform design verification and transfer to production.
- Customer: Work directly with Clinicians to review product performance. Gain feedback and implement changes based on clinician feedback. You will be spending time with the customer and the patient. Ability to understand customer requirements and translate those requirements into product designs is required for effective performance in this position.
- Team Work: Serve as a lead technical role on the project team. The incumbent will work closely with fellow R&D engineers, Customers, Marketing, Sales and Manufacturing regarding New Product Development. The position requires a team-oriented individual with strong interpersonal skills.
- Efficiency: Experienced in managing projects with tight timelines and budgets in highly matrix organization. Self-driven and always look for more efficient and effective ways of achieving results.
What is expected of you for success in your role
- Demonstrates comprehensive experience in product design and development
- Demonstrates comprehensive knowledge of Engineering principles and its application in solving complex problems
- Demonstrates comprehensive working knowledge of the design control process as well as completing FMEA and Risk analysis
- Uses advanced analysis tools and methods to solve complex technical problems (e.g. 3-D Modeling and Design, Computational Fluid Dynamics, and Finite Element Analysis)
- Working with cross-functional team, establishes customer needs, translates needs into product requirements and verifies design output meets design input
- Works independently and with teams (technical teams and cross-functional teams) to create complex designs
- Evaluates and appliesdesigntradeoffs and constraints for design optimization
- Independently tests, analyzes and solves technical problems
- Applies advanced statistical techniques and utilizes design of experiments
- Assists in due diligence on new technology, license or acquisition opportunities
- Drives the intellectual property strategy for a product family
- Bachelor's degree in Engineering (Mechanical, Plastics, Biomedical) required
- A minimum of 10+ years related work experiencerequired, preferredMS or PhD
- Previous experience with disposable medical devices in a high-volume manufacturing environment required
- Previous experience in a highly regulated environment for Class II disposable medical devicesrequired
- Very good understanding of plastic part design, injection molding, extrusion, and manufacturing processes
- Experience in the design of complex engineering grade plastic parts, mold design, and processing of engineering grade resins
- Ability to train and coach others from technical expertise
- Solid experience with Solidworks preferred
- Solid experience with DFSS preferred
Primary Work Location
USA CA - Yorba Linda
Job ID R-308058