Principle Electrical Engineer

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 ? Establishes, executes, and reports on product development deliverables taking projects from concept to launch.
? Conducts product testing, creates models, and prototypes, and provides constructive feedback to design engineers.
? Champions projects through the product development process.
Performs clinical and preclinical assessments.
? Conducts project management tasks & documentation with design controls and risk analysis in accordance with established SOPs.
? Incorporates required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the design history file.
? Prepares reports, presentations and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, surgeons, customers.
? Collaborates with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
? Provides strategic vision. Work on highly complex technical problems and provide solutions that are highly innovative and ingenious to a broad range of problems.
? Trains and mentor others in specialized area. Adheres to safety policy and procedures.
? Excellent communication skills both oral and written.
? Effectively communicate and works cooperatively with others as part of a team.
? Ability to compile and organize technical data using Excel, Word, or Access.
? Thorough understanding of engineering practices, product safety and root cause analysis.




? In-depth understanding of medical device industry and competitor products. Complete knowledge of other related disciplines including cross functional fields and market competition.
? Deep understanding of clinical and regulatory pathways, IP and internal processes. Working knowledge of applicable FDA and ISO standards. Knowledge of GMP for tooling, molding, design and process methods.
? Complete understanding of anatomy relative to surgical procedures for specific products.
In depth knowledge and application of investigative research and analysis.
? Thorough knowledge of laboratory instrumentation and computer software skills utilizing research-based applications.
? Working knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals and materials. In depth knowledge and experience in transferring designs to manufacturing.
? Working knowledge of mechanical design and development of complex medical devices.
? Working knowledge of rapid prototyping, material selection, product design, and process specs.
? Working knowledge of Design for Six Sigma, Failure Mode Effects Analysis, Statistical Analysis methods, and Design of Experiments.
? Knowledge and experience with medical device materials and biocompatibility testing.
? Working knowledge of preclinical study designs, execution and interpretation of results.
? In depth knowledge and application of CAD (Pro/Engineer) design
? Bachelor’s plus a minimum of 10 years' relevant experience; or Master’s plus a minimum of 8 years' relevant experience; or PhD plus a minimum of 5 years' relevant experience.
? Education in Engineering, Scientific or Technical discipline required. 2 years' medical device/ pharma experience preferred.