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Mechanical Design Engineer


Requisition Number: P12141

Region: US
State: Wisconsin
City: Hudson

Responsibilities

  • Generate product designs that meet product requirements
  • Identify and analyze design risks using tools such as tolerance analysis, static or dynamic simulation or hand calculations.
  • Develop appropriate design risk mitigations and test strategies
  • Work with production facilities to understand and incorporate production intent design for manufacturing (component level) and design for assembly (assembly level) into the design.
  • Develop appropriate assembly and test fixtures to aide in the manufacture and testing of the design,
  • Integrate the electronic elements into the product design
  • Develop appropriate drawings to detail product and assembly specifications in a manner compliant with ASME or other design standards
  • Maintain a design journal that identifies product risk and tracks design changes throughout the Design Development Process.
  • Generate Database Approval Forms and Engineering Change Orders to document design changes and customer approval.
  • Identify and assess Design Risk via a dFMEA
  • As needed, organize and lead internal and external technical meetings and publish notes.
  • As needed, procure printed and machined prototypes to assess your design.
  • Improve existing designs provided by our customers or production sites:
  • Identify potential manufacturing risks within the design of the components and assembly.
  • Apply good Design for Manufacturing and Assembly principles to the design
  • Use or coordinate appropriate analytical techniques such as Tolerance Analysis, MoldFlow, SWX Simulation, SWX Plastics or ANSYS to aide in the analysis of the design
  • As needed, design fixtures to aide in assembly, testing or inspection.
  • Serve as a consultant to design and production resources on engineering related issues
  • Provide independent review of peer and customer designs
  • Participate in collaborative brainstorming (JumpStart®) sessions.
  • Support program or project management by:
  • Assist with the creation of scope, cost and duration estimates for various tasks
  • Support program/project management and customer needs by being accountable for meeting project timelines and ensuring activities are supported by the project budgets.
  • Ensure that design inputs and outputs are properly documented and controlled according to relevant procedures.
  • Generate and control Drawings and Specifications according to relevant work instructions
  • Facilitate communication between team members, customer and flow through production facilities 
  • Operate primary CAD systems such as SolidWorks or Creo
  • Travel to Customer and PMC facilities as required to support business needs
  • Other duties as assigned

Qualifications - Education & Experience

  • Bachelor of Science in Mechanical Design or Engineering
  • Minimum 7 years of experience in the design of mechanical or electro-mechanical drug / biologic delivery devices (pen injectors, auto-injectors and wearable pumps).
  • Plastic injection molding and product development
  • Design experience with medical devices or similar products
  • Strong Design for Manufacturability experience focusing on plastic injection molding and plastic assembly methods (snaps, sonic welding, press fit, sealing, etc)
  • Proven history of providing innovative design solutions
  • Experience performing tolerance analysis and structural analysis
  • Diverse product portfolio

Qualifications - Skills & Competencies

  • Familiar with ISO 13485 and ISO 14971
  • Ability to generate complex surface models
  • Familiar with various plastic materials and design limitations or potential design risks for said materials
  • Strong ability to interact with team members and customers in a professional manner
  • Ability to mentor and coach peers and others in applicable design software, standards and processes
  • Strong written and verbal communication skills; ability to communicate design intent to a diverse audience
  • Experienced understanding of injection mold operation
  • Understanding of the behavior of plastics and other materials as they relate to mechanics, function and creep
  • Demonstrates strong ability to evaluate and recommend appropriate prototyping processes (i.e. SLA, printed, machined, molded)
  • Ability to think outside of box, and assist others in doing so
  • Ability to define, create and interpret mechanical drawings
  • Proficient in the application of GD&T
  • Proficient in computer tools and systems including MS Office
  • Maintains and respects customer, project, and program confidentiality
  • Motivated self-starter who is able to manage multiple tasks

 

This facility operates under International Traffic in Arms Regulations (ITAR), and therefore, any person hired must demonstrate with verifiable documentation that he/she is either: (i) a U.S. Citizen; (ii) an active Green Card Holder; or (iii) a “Protected Person” as defined by 8 U.S.C. 1324(b)(a)(3).

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