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Mechanical Engineer IV

2 months ago

goleta, United States KARL STORZ Endoscopy - America Full time
Job Description

JOB SUMMARY: 

 

The Mechanical Engineer IV is responsible for the mechanical design of new products.  He/she will interpret product requirements and lead the development of new product designs that meet those requirements.  The Mechanical Engineer IV will organize the mechanical development process, direct the work of Mechanical Designers, and represent the mechanical discipline on project teams.  He/she will conceptualize, design, analyze, and test mechanical components, mechanical assemblies, and optical assemblies used in medical and industrial imaging systems. He/she will approve the final product designs, provide technical advice and assistance to the more junior Mechanical Engineers, and be responsible for design documentation.  

 

The Mechanical Engineer IV will also lead the research and development of new mechanical, opto/electro/mechanical, and materials technologies for use in future products. He/she will define, plan, coordinate, and execute tasks for innovation projects leading to the testing, recommendation, and demonstration of prototypes that that can be transferred into product development projects. 

 

The Mechanical Engineer IV will have a strong knowledge of KARL STORZ products or other similar medical devices and the mechanical fundamentals; as well as and a high degree of proficiency with the tools required to efficiently produce high quality product designs.  He/she will have the experience and capability to independently manage more complex product development or innovation projects. 

 

The Mechanical Engineer IV will also provide sustaining support for existing product lines as well as lead the development and implementation of Mechanical Department processes and procedures. 

 

ESSENTIAL FUNCTIONS:

 

Project Development: 

  • Responsible for mechanical design of new products.   
  • Represent the mechanical discipline on project teams and be accountable for mechanical project deliverables; interface with project team members in a positive and professional manner to achieve high quality, cost effective designs that best meet product requirements. 
  • Develop new product designs that meet product requirements; create concept designs, evaluate trade-offs, and communicate design status with Project Managers and project teams. 
  • Perform the various forms of analysis necessary to develop a robust design that meets the product requirements; including structural (FEA), thermal (CFD), tolerance, torque values, etc.  Document and communicate analytical results with the project teams. Determine, where appropriate, empirical methods to validate analytical models and update the model assumptions as needed to correlate the results. 
  • Coordinate work with Mechanical Designers to transform design concepts into component and assembly models/drawings; direct and review Mechanical Designers tasks. 
  • Approve models and drawings; certifying that a design meets all product requirements and industry standards. 
  • Provide technical advice and assistance to the more junior Mechanical Engineers. 
  • Responsible for design documentation and ensuring compliance with our quality system; including creation of BOM, solid models, detail drawings, and mechanical items in the design history file (GPDP documentation).   
  • Interpret and negotiate user needs and product requirements. 
  • Contribute to the definition and estimation of work required, and independently organize and prioritize project deliverables. 
  • Interface with Manufacturing and Quality Engineers on the implementation of new product designs into production. 
  • Communicate with Purchasing and vendors to establish new capabilities or processes required to produce new designs. 
  • Provide support and technical direction to Test Engineers for mechanical aspects of design verification testing; perform engineering testing of prototype assemblies and write test reports. 

   

Research and Development: 

  • Lead the research and development of new mechanical, opto-mechanical, electro-mechanical, and materials technologies for use in future products. 
  • Define, plan, coordinate, and execute tasks for innovation projects. 
  • Produce demo hardware and documentation for innovation projects. 

   

Sustaining: 

  • Provide sustaining support for existing product lines, which may include analysis of or developing solutions for manufacturing or field issues. 
  • Assist Sustaining Engineers by providing background information on design intent and with the validation of proposed changes. 
  • Review and approve EC’s as needed. 

   

Mechanical Department: 

  • Responsible for overall quality and timeliness of mechanical designs. 
  • Lead the improvement of design, manufacturing, and assembly processes. 
  • Provide critical review of designs and analysis of other Mechanical Engineers. 
  • Provide training, assistance, and help coordinating work of Mechanical Engineers, Mechanical Designers, and Interns. 
  • Contribute to the development and maintenance of departmental procedures as directed. 
  • May spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KSI’s products and services. 
  • Regular attendance is an essential job function 

 

ADDITIONAL RESPONSIBILITES: 

 

  • Submit ProjectServer timesheets weekly. 
  • Attend department team meetings, one on one meetings, and company meetings as required. 
  • Complete training assignments as required. 
  •  Performs other related duties as assigned by manager. 

 

KNOWLEDGE, SKILLS, ABILITIES: 

  • Expert level of proficiency with computer aided drafting (CAD) software, preferably SolidWorks, to model parts/assemblies and create drawings; including knowledge of surfacing, sheet metal, and CircuitWorks. 
  • Strong knowledge of optical design formulas, optical materials, coatings, adhesives, sealing techniques, and mechanical constraints of opto-mechanical designs. 
  • Strong knowledge of mechanical design practices for packaging of electronics. 
  • High level of level of proficiency with computer simulation, preferably in SolidWorks, especially finite element analysis (FEA) and computational fluid dynamics (CFD). 
  • Expert level of proficiency in performing tolerance studies on assembly components using CAD tools and ability to optimize design tolerances for functionality and manufacturability, including a strong understanding of standard inspection and measuring techniques. 
  • High level of proficiency with Product Lifecycle Management tools, especially SAP and CAD Desktop. 
  • Expert level proficiency with industry accepted drafting standards; including ASME Y14.5 Geometric Dimensioning and Tolerancing. 
  • Proficiency with KeyShot or SolidWorks Visulalize to produce photorealistic renderings preferred. 
  • Strong knowledge of manufacturing processes, including machining operations, metal finishes, sheet metal, injection molding, and printed circuit boards.  Ability to design close tolerance assemblies for functionality and manufacturability. 
  •  High level of proficiency with medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485/ISO9001, IEC60601). 
  •  An enthusiastic team player who excels on interdisciplinary teams to achieve common goals. 
  •  Excellent time management skills and the ability to prioritize to effectively manage multiple and disparate demands. 
  •  Professional approach to your work is expected including being highly organized, maintaining accurate records of your progress, and a disciplined, detail oriented follow through on projects. 
  •   An excellent communicator, with very good written and oral skills for communicating technical information. 

 

EDUCATION AND EXPERIENCE:  

 

  • Bachelors of Science degree in Mechanical Engineering, Physics, or related field with more than ten (10+) years of experience or either a Master of Science or Doctorate degree in Mechanical Engineering, Physics, or related field with more than eight (8+) years of experience in mechanical, opt-mechanical, or electro-mechanical design required. 
  • Experience with camera systems for endoscopy or similar medical devices preferred. 

 

PHYSICAL & MENTAL REQUIREMENTS: 

 

  • Ability to sit for extended periods (during meetings or using desktop computer). 
  • Adequate vision and manual dexterity for CAD modeling, precision assembly, and product testing. 
  • Ability to work with hand tools for prototype assembly. 
  • Work effectively under pressure and time constraints. 
  • Communicate clearly with manager and co-workers. 

 

TRAINING REQUIREMENTS: 

 

  • Injury and Illness Prevention Program; annually - OSHA requirement 
  • Bloodborne Pathogen; annually – OSHA requirement 
  • Quality System training 
  • Mechanical Engineer Job Specific - In house requirement 

 

SUPERVISORY RESPONSIBILITIES:  

 

  •  Mechanical Designers - delegate project tasks to Mechanical Designers; provide instruction and oversight of their efforts (not a direct reporting relationship). 

 

LEVEL OF SUPERVISION REQUIRED: 

 

  • The department manager develops general goals for the employee at the yearly review cycles, which are derived from the overall company goals; tasks are derived from these general goals by the employee and reviewed and accepted by the department manager. 
  • The department manager assigns Mechanical Engineers to project teams and assigns non-project tasks as needed. 
  • A detailed review of work accomplished is required and scheduled as needed; reviews are conducted by peers, project teams, and/or department manager. 
  • Must possess the ability to independently prioritize workload to meet timelines, and communicate proactively to resolve conflicts.
  • One-on-one meetings with department manager at a frequency no less than monthly. 

 

INTERFACE:

 

  •     Product Managers – to understand user needs and design requirements 
  •     Project Managers, Systems Engineers, and project teams – for design and schedule requirements. 
  •     Mechanical Engineers – to support other development projects as needed. 
  •     Mechanical Designers – to provide direction, oversight, and approval of design and project tasks. 
  •     Electronics Engineers and Layout – to define design requirements and electro-mechanical interfaces. 
  •     Test Engineers – for design verification testing. 
  •     Manufacturing and Quality Engineers – for manufacturability issues. 
  •     Purchasing and vendors - to explore solutions and resolve issues with fabrication of components or assemblies. 
  •     Regulatory staff – for compliance related specifications and to respond to inquiries. 
  •     New Manufacturing Technology Engineers – to support development of new manufacturing processes. 
  •     Sustaining Engineers – to support maintenance of existing product designs. 
  •     Document Control – for creation, release, and storage of data/documents. 

 

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