Mechanical Design Engineer III

MPE-, Inc.

$85K — $100K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Mechanical Engineering
  • 5+ years proficiency in SolidWorks
  • Experience with Creo
  • Strong understanding of GD&T and sheet metal design
  • Familiarity with IEC 60601-1 and FDA regulations
  • Ability to draft and interpret technical drawings
  • Experienced in medical device design and development

Responsibilities

  • Conduct mechanical CAD work based on input from various stakeholders.
  • Manage ERP system data to ensure design accuracy.
  • Interface with customers, suppliers, and team members.
  • Present design concepts and progress to stakeholders.
  • Apply regulatory specifications to design processes.
  • Travel to support design and production startup at customer sites.
  • Document and troubleshoot issues during product transfer to manufacturing.

Benefits

  • Dynamic work environment with opportunities for travel
  • Hands-on involvement in prototype building and testing
  • Continuous learning and professional development encouraged
  • Collaboration with cross-functional teams
  • Opportunity to work in the medical device industry
Full Job Description
Job Summary:

The Design Engineer III is responsible for all activities surrounding the physical customer deliverable during the development phase. Additional responsibilities include, design documentation, physical labor to build / test / refine physical prototypes, travel to suppliers, customers and application sites.

Essential Duties and Responsibilities:

  • Detailed mechanical CAD work based on internal and external input.
  • ERP system data input / management to ensure design data reflects accurate information.
  • Interface with customers, suppliers and internal personnel.
  • Presentations to customers, suppliers, and internal stakeholders.
  • Understand and apply specifications and regulatory information to the design and relevant processes.
  • Travel to customer sites to assist with design, test and startup production.
  • Work within established, as well as variable, timelines.
  • Effectively utilize Microsoft Office tools.
  • Conduct DFMEA internally and/or with customer participation.
  • Complete and maintain all required paperwork, records and documents as they relate to Engineering.
  • Transfer new products to manufacturing. Assist associates to perform initial build, document issues, and troubleshoot opportunities for improvement.
  • Self-motivate to improve knowledge, skills, and experience in clinical applications and Engineering.
  • Follow and comply with all safety and work rules and regulations.
  • Maintain departmental housekeeping standards.

Education

  • Bachelor Degree in Mechanical Engineering

Experience and/or Training

  • Proven competency in Soildworks at least 5+ years
  • Experience with Creo
  • Sheet metal design
  • GD&T
  • Knowledge of IEC 60601-1 standard and/or FDA regulatory requirements
  • Five plus years' experience in medical device design
  • Strong computer, math and oral/written communication skills and attention to detail required
  • Ability to create / read drawings
  • Understand and determine tolerance stack up information
  • Knowledge of tooled processes such as cast, injection mold, pressure form, etc.
  • Ability to run a technical presentation and speak professionally
  • Proficient using hand tools and working with fabrication personnel
  • Knowledge of different weld processes and when to apply them

Physical and Mental Demands

  • Continuous: Seeing, hearing, reading, writing, sitting, comprehending instructions, correspondence, regulatory and specification information, computer usage
  • Frequently: Math, problem-solving, close-up vision,
  • Intermittent: Machine use, fine motor skills, lifting 50 pounds

Work Environment

  • General office environment, may require to go onto production floor where PPE is needed, and may be warm/cool depending on temperature, and sound levels are moderate.

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