STAFF MECHANICAL ENGINEER Job in Irvine, California US
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson Johnson's Family of Companies, is currently recruiting for a Staff Engineer located in Irvine, California.
ASP (Advanced Sterilization Products), a member of the Johnson Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj .
Apply knowledge of general mechanical engineering principles, heat transfer, thermodynamics, statics and dynamics, calculate stress strain values, formulate tolerance stack-ups, application of materials, DFMA reliability to achieve product design requirements. Work one-on-one with customer stakeholders to identify product opportunities and evaluate potential technical solutions. Interpret customer marketing input to define technical design requirements. Maintain idea notebooks. Utilize QFD (quality function deployment), VOC (voice of customer) methodologies Sterilization knowledge to define product design options. Provide innovative product, system component design solutions. Perform detailed design analysis 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 design concepts, create prototypes and complete verifications. Provide support to patent attorneys for patent filing. Consult with materials technology group material compatibility approvals. Assist in developing monitoring project plan, budget, contingency plans work estimation. Coordinate integration of complex sub-system product designs. Provide technical leadership to product development team. Learn medical terminology, procedures instrumentation. Provide peer feedback may mentor junior associates as required.
Represents an authority within company in his/her field. Develops solutions to complex problems which require the regular use of ingenuity and creativity. Work is performed with little or no supervision. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long term perspective, for desired results.
Physical Demands: Walking, standing and sitting for extended periods.
Work Environment: Office environment
Supervisory Responsibilities: Team Leader. May take a technical lead on projects
Environmental Health and Safety: All employees have a duty to care for their safety and for the safety of others whom may be affected by their acts or omissions at work and the environment. Other responsibilities may be assigned not all responsibilities listed may be assigned.
Qualifications
BS or MS engineering degree (preferably Mechanical Engineering), with 8+ years of design-related experience and 2 years of medical device design required (. Knowledge of general design engineering and DFMA principles, component manufacturing processes, tooling methodologies, material properties, and regulatory compliance required. Experience with Electro-mechanical design, CAD (Solid Works, a minimum of one year is required) and design analysis software, and statistical analysis techniques required. This role will also require outstanding leadership capabilities with the innate talent to work in a cross-functional team environment. Networking and the ability to communicate with outside sources well is a desired trait in our design engineers. Basic knowledge understanding of medical regulatory requirements. Technical writing: protocols, testing results, procedures, status special reports. Project management and Leadership skills .Knowledge understanding of medical regulations their impact on business, ISO (International Organization for Standardization) GMP (Good Manufacturing Practices). Information risk analysis skills. Quality, statistical process controls . Knowledge of part manufacturing processes tooling methodologies. Effective team interpersonal skills. Conflict analysis resolution. Consulting, design review, constructive feedback Negotiating (e.g., internal external customers), Networking, Able to adapt to shifting priorities, Able to handle rapid pace environment. Able to resolve problems / conflicts, Able to take initiative be self-managing. General design engineering principles, Design of experiments (DOE), DFMA (design for manufacturing and assembly) principles, Patent interpretation,
(MECHANICAL):Free-body stress-strain analysis FEA (finite element analysis),Geometric tolerance tolerance stack-up analysis (GDT).Gage repeatability re-calibration system methodology, Plastic resins, ferrous nonferrous metals, adhesives sealants.