Senior Systems Engineer

4 weeks ago


Waukegan, Illinois, United States Spectraforce Technologies Full time
Job Title: Senior Systems Engineer

We are seeking a highly skilled Senior Systems Engineer to join our Product Development team at Spectraforce Technologies. As a key member of our team, you will be responsible for the development and launch of new commercial drug/device combination products.

Key Responsibilities:
  • Contribute to the development and launch of new commercial drug/device combination products
  • Collaborate with cross-functional teams to ensure the development of a robust patient-centric product design and reliable performance
  • Develop and foster relationships with Engineering Services firms and third-party development partners
  • Drive the implementation of appropriate product development engineering principles within the Design Controls process
  • Responsible for integration of inputs and risks from multiple disciplines to ensure the development of a robust patient-centric product design and reliable performance
Requirements:
  • BS in Engineering, Science, or closely related discipline with 3+ years of experience or MS or higher with 2+ years of experience
  • Ability to multitask and work within timelines
  • Demonstrated scientific writing skills and strong verbal communication skills
Preferred Qualifications:
  • Expertise in product development from initial concept to release to market
  • Experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR
  • Strong analytical and communication skills
What We Offer:
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced Senior Systems Engineer looking for a new challenge, please submit your application.



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