Senior Mechanical Design Engineer - Medical Devices

Agiliti

Wauwatosa (WI)

On-site

USD 110,000 - 170,000

Full time

14 days+

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Benefits offered by this job

Health insurance
401K matching
Paid Time Off
Tuition Reimbursement
Employee discounts

Job summary

Agiliti is seeking a Senior Mechanical Engineer to lead multiple complex projects in collaboration with stakeholders across Engineering, Quality/Regulatory, and Certification teams. You will drive design from kickoff to implementation, ensuring cost, schedule, and performance goals are met with robust 3D CAD models and rigorous design review processes.

You will oversee prototype fabrication, tooling reviews, and production transfer while maintaining high standards for regulatory compliance and

Qualifications

  • Proven track record leading complex medical device projects
  • Experience with ISO/IEC/FDA standards for certifications
  • Ability to travel up to 50% (Domestic and International)
  • Experience with mass production processes (injection molding, etc.)
  • Proven collaboration across multiple disciplines and teams

Responsibilities

  • Act as technical lead on multiple complex, integrated projects
  • Ensure system integration across projects
  • Develop innovative design processes meeting quality, cost and delivery goals
  • Create electro-mechanical designs using 3D CAD tools
  • Contribute to risk analysis, usability, verification and certification
  • Oversee prototype development and fabrication of working models
  • Communicate project challenges to cross-functional teams and leadership
  • Review tooling designs and support transfer to mass production
  • Design and review fixtures and production samples; analyze field returns for root cause
  • Guide team leaders and raise issues/risks with cross-functional management
  • Lead project update presentations and design reviews with visuals

Skills

3D CAD
Inventor
SolidWorks
FEA
DFMEA
Regulatory standards
Communication
Travel up to 50%

Education

BS Engineering

Tools

Jira
Monday.com
Todoist

Job description

Agiliti is seeking a Senior Mechanical Engineer to lead multiple complex projects in collaboration with stakeholders across Engineering, Quality/Regulatory, and Certification teams. You will drive design from kickoff to implementation, ensuring cost, schedule, and performance goals are met with robust 3D CAD models and rigorous design review processes.

You will oversee prototype fabrication, tooling reviews, and production transfer while maintaining high standards for regulatory compliance and

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