Job Description Position Overview: Phillips-Medisize, LLC is seeking a Senior Mechanical Design Engineer todesign and develop medical device and drug delivery products, following the Phillips-Medisize Design Development Process (DDP) and applicable standards such as ISO 13485 with design controls, ISO 14971 and appropriate ASME standards.
Operate primary CAD systems such as SolidWorks or Creo
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
Identify potential manufacturing risks within the design of the components and assembly.
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
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
Other duties as assigned
Job Number 7965BR
Career Field Engineering
Position Qualifications Required Qualifications:
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
Skills and Abilities:
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 material
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)
Maintains and respects customer, project, and program confidentiality
Motivated self-starter who is able to manage multiple tasks
This position does not qualify for VISA sponsorship 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) ac active Green Card Holder; pr (iii) a "Protected Person" as defined by 8 U.S.C. 1324(b)(a)(3).
About Phillips-Medisize, LLC... Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets. Learn more... Visit us: Twitter: YouTube: Linkedin: Phillips-Medisize History:
Location Hudson, WI 54016
Equal Opportunity Employer We are an equal opportunity employer. Minority/Female/Disabled/Veteran This employer uses E-Verify. Please visit the following website for additional information: