Senior Medical Device Applications Engineer (Proposals)

Cirtec Services GmbH

Brooklyn Park (MN)

On-site

USD 100,000 - 135,000

Full time

3 days ago
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Job summary

Cirtec Medical Corporation is seeking a Sr. Applications Engineer to generate proposals for mechanical devices and high-precision components, while supporting teams in implantable product development.

You’ll collect and organize cost data for complex development proposals and build networks to analyze new opportunities. The role requires hands-on experience in medical device development from design to production, strong ISO 13485 and FDA 21 CFR 820 knowledge, and the ability to read technical

Qualifications

  • Bachelor's degree in a STEM field required.
  • 5+ years of Applications Engineering experience.
  • Experience in mechanical/tool design and manufacturing (medical devices preferred).
  • Experience on medical device development projects from design through production.
  • Strong understanding of ISO 13485 and FDA 21CFR820 Quality Systems.

Responsibilities

  • Collaborate with cross-functional teams to define development plans and budgets.
  • Evaluate technical solutions for customer development requests.
  • Prepare budgets and quotations for development programs.
  • Write proposals with clear technical communication and visuals.
  • Lead peer reviews and management reviews for proposals.
  • Provide technical leadership to program teams.
  • Support technical strategies and risk assessment for PDP programs.
  • Guide teams through Cirtec's Product Development Process for mechanical assemblies.

Skills

5 years experienc e in Apps Eng
Mechanical design
Tool design
Manufacturing processes
Medical device development
ISO 13485 & FDA 21 CFR 820
Reading drawings
Fluent English
Willingness to travel
MS Office

Education

Bachelor's degree in STEM

Tools

MS Office

Job description

Cirtec Medical Corporation is seeking a Sr. Applications Engineer to generate proposals for mechanical devices and high-precision components, while supporting teams in implantable product development.

You’ll collect and organize cost data for complex development proposals and build networks to analyze new opportunities. The role requires hands-on experience in medical device development from design to production, strong ISO 13485 and FDA 21 CFR 820 knowledge, and the ability to read technical

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