Principal Device Engineer

Open Position:
Principal Device Engineer

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. Fulfills technical lead role and creates client specific deliverables to support development or lifecycle management activities.

• 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 and/or manages development of testing documentation needed to support characterization, method development, method validation, and device design verification testing activities.
• Fulfills technical lead role on multiple device development and testing project with minimal supervision.
• Supervise engineers, technologists, technicians, and/or interns directly or indirectly as needed.
• Proactively identifies areas of project and/or technical risk, escalates issues in an expedient manner, and actively proposes solutions.
• Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.
• Maintains a culture of continuous improvement while accelerating delivery of commitments

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 (Biomedical or Mechanical) required.
• 7+ years of experience in medical device/combination product development and designing/executing design verification and test method validations.
• Familiarity with ISO 14971:2007, 13485:2016, and 21
  
  CFR
  820 required.
• Strong 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 Mini Tab and Microsoft Project is strongly preferred.
• Familiarity with ISO 11040-4, 11040-8 and 11608-1,
  -2 and
  -3 preferred.
• Manage internal and external relationships.

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.