Sr Engineer (R&D)
Orange County Metro Area, CA
The Sr. Engineer, Research & Development will support the Critical Care Mechanical team working on new product designs, technology development and sustaining of core product lines with an emphasis on hands on new product development.
- Support the development of critical care devices or subsystems thereof from concept to commercial launch
- Apply engineering principles to the design of electro mechanical medical devices, effectively use tests and simulations to expedite development in a fast paced environment
- Design, prototype and test components of medical devices, develop new test methods to evaluate devices
- Work with internal and external resources to contribute to the design and development, testing and release of electromechanical components used in medical device systems
- Solve technical issues working as a contributing member of a diverse engineering team
- Integrate development of medical technology by assuring the design of technology interfaces and system elements works together as a whole
- Write design verification and validation protocols and reports in accordance with quality procedures assuming full ownership as the Study Director
- Provide solutions to the technical aspects of product design and development as well as the translation of marketing requirements into product specifications
- Work with R&D technical teams (Mechanical, Electrical, Systems, Software) and internal partners in the Marketing, Regulatory, Quality, Clinical, Manufacturing and other departments to deliver project objectives
- Must have good 3D CAD skills in SolidWorks
- Must have demonstrated the ability to solve engineering problems, through testing, analysis, simulation (FEA, CFD) modeling etc.
- Working knowledge of basic statistics and six-sigma principles
- Requires strong technical aptitude, leadership, communication, writing and coordination skills
- Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills
- Must be a highly motivated self-starter who is able to achieve results with minimal direction
- Must be proactive and creative in achieving goals
- Must have strong conflict resolution skills
- Previous mechanical design experience with disposable devices, capital equipment, and/or sensors (pressure, flow, optical).
- Proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
- Experience in design verification & validation within an FDA regulated industry
- Experience with design control procedures
- Experience with Solidworks, LabView, MatLab, and quantitative analysis of data
- Knowledge of relevant manufacturing processes like injection molding, extrusion etc.
- Comfortable in a dynamic working environment with multiple priorities
- Bachelor s Degree in Mechanical Engineering with a minimum of 5 years experience (Master s or PhD degree lessens the experience required for the position)