Open Position: Device Engineer II

Function:  Engineering

Summary

Applies a solid understanding of medical device/combination product development toward the development of new products and remediation of Design History Files and testing programs. Creates client specific deliverables to support development or lifecycle management activities.

Please send your resume and a cover letter to careers@edgeonemedical.com and include Device Engineer II in the Title.

Essential Duties and Responsibilities

  • Executes creation of new product development and lifecycle management deliverables for medical devices and/or combination products, including plans, product requirements and risk documentation, on time and within project budget. 
  • Generates documentation needed to support characterization, method development, method validation, and device design verification testing activities. May supervise test operators.
  • May independently plan, schedule and lead small testing projects within a broader project.
  • Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions.
  • Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.
  • Assures laboratory activities are conducted in compliance with all applicable EdgeOne or client training and GLP requirements.
  • Maintains a culture of continuous improvement while accelerating delivery of commitments.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Bachelor’s degree in Engineering and Masters in Engineering, strongly preferred.
  •  3-5 years of experience in medical device development, and designing/executing design verification and test method validations.
  •  Familiarity with ISO 14971:2007, 13485:2016, and 21CFR820 required.
  •  Strong multi-tasking, time management, technical writing, and communication skills are required.
  •  Highly motivated self-starter who can work with minimal supervision or as part of team.
  •  Ability to problem solve and identify root causes as part of investigations.
  • Working knowledge of MiniTab and Microsoft Project is strongly preferred.
  • Familiarity with ISO 11040-4, 11040-8 and 11608-1, -2 and -3 preferred. 
  • Working knowledge of experimental design statistical analysis is preferred.
  • Experience leading the development of testing protocols and reports is preferred.
  • Manage internal and external relationships.

Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.