强生(苏州)医疗器材有限公司（R&D Engineer (Biomedical Materials)）

SCOPE OF THE ROLE AND BASIC PURPOSE-This job description covers skills and responsibilities of the RD Product Design Engineer position located in the Ethicon China RD facility.
-The Product Design Engineer is responsible for:Interacting with customers,such as surgeons and medical professionals to understand market needs;executing specific and general assignments that establish the feasibility of innovative,functional product concept designs;and/or,Executing specific and general assignments that provide innovative,functional,cost effective and validated product designs.
ACCOUNTABILITIES/KEY MEASURES
-Apply knowledge of general engineering principles,materials,DFMA and reliability to achieve product design requirements.
-Work one-on-one with customer stakeholders to identify procedure and/or product opportunities and evaluate potential technical solutions.
-Interpret customer and marketing input to define technical design requirements.
-Maintain idea notebooks.
-Utilize JOC(jobs,outcomes and constraints),VOC(voice of customer)methodologies and surgical procedure knowledge to define product and design options.
-Provide innovative product,system and component design solutions.
-Perform detailed design analysis and provide input or approval for detailed design specifications.
-Establish appropriate testing strategy to insure adequate safety factors or margins.
-Perform product testing to insure adequate safety factors or margins.
-Formalize concepts,breadboards and prototyping.
-Provide support to patent attorneys for patent filing.
-Consult with materials technology group for biomaterial approvals.
-Assist in developing and monitoring project plan,budget,contingency plans and work estimation.
-Coordinate integration of complex sub-system product designs.
-Provide technical leadership to product development team.
-Learn medical terminology,procedures and instrumentation.
-Provide peer feedback and may mentor junior associates as required.
-Technical(Mechanical):Develop free-body diagrams;Calculate stress and strain values;Formulate tolerance stack-ups.
-Technical(Electrical):Model electromagnetic and electromechanical devices and systems:Calculate product parameters to provide adequate insulation to prevent voltage breakdown;Design electromagnetic devices for tissue models with guidance from upper level engineers.
-Develop error budget analyses of electromagnetic and electromechanical systems.
-Other responsibilities may be assigned and not all responsibilities listed may be assigned.Required Competencies and Skills-BS or MS engineering degree,or extensive knowledge and industrial experience coupled with demonstrated accomplishments.
-5+years of design-related experience required,preferably in medical products or device industry working in a team base environment.
-Basic knowledge and understanding of medical regulatory requirements
-Effective oral,written,presentation communications in English/Mandarin
-Technical writing:protocols,testing results,procedures,status and special reports
-Knowledge and understanding of medical regulations,their impact on business,ISO(International Organization for Standardization),GMP(Good Manufacturing Practices)
-Information and risk analysis skills
-Quality,statistical process controls
-Knowledge of part manufacturing processes and tooling methodologies
-Effective team interpersonal skills and the ability to work effectively within diverse cultural environments
-Conflict analysis and resolution
-Consulting,design review and constructive feedback
-General design engineering principles
-Design of experiments(DOE)
-DFMA(design for manufacturing and assembly)principles
-Patent interpretation
-Test development and execution
-Technical(Mechanical):Free-body,stress-strain analysis,FEA(finite element analysis);Geometric tolerance,tolerance stack-up analysis;Gage repeatability,re-calibration system,methodology
Plastic resins,ferrous and nonferrous metals,adhesives and sealants
-TECHNICAL(ELECTRICAL):System modeling with circuit simulation software and CAD,Analog,digital or signal processing circuitry,
Stand-alone microprocessor based medical systems used for diagnostic or therapeutic purposes,AC,DC,and RF generators or power ultrasonic medical device.
-COMPUTER SKILLS:
Personal computer software-Windows:word processing,project planning,presentation,e-mail and spreadsheet software
Special design analysis software,(e.g.,FEA,mold flow)
CAD/CAM software proficiency
Internet search skills