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Job Summary:  The Engineer contributes to the delivery of regulatory and quality solutions to enable client success. The Engineer prepares work products and executes the defined consulting scope of work, with assistance of more experienced consultants as needed.

Key Areas of Demonstrated Competence: 5 R&Q Knowledge Areas

Depending on the individual client assignment(s), the Engineer may perform the following essential duties:

  • Provides daily regulatory and quality hands-on support to clients under the direct supervision of an experienced consultant
  • Contributes in the drafting of worldwide regulatory strategies and worldwide regulatory submissions
  • Contributes with Quality System Development programs as well as Quality System improvement programs
  • Contributes to quality audits and audit preparation of clients
  • Contributes to design assurance activities: safety risk management, usability, design verification and design validation
  • Contributes to process validation and other related quality manufacturing tasks
  • Contributes in the definition of supplier quality specifications and other supplier qualification activities
  • Contributes to supplier audits
  • Conducts post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities under supervision
  • Coordinates recall activities as directed by an experienced consultant


Project Resource Responsibility

  • Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
  • Communicates project risk and issues to the project lead in a timely fashion

Sales and Marketing

  • Identifies potential new customers, pursues conversations regarding R&Q capabilities, and creates connections for the Sales Team
  • Builds relationships with customers and identifies new customer needs and requirements
  • Develops and cultivates a strong medical device industry network to provide connections to the Sales Team
  • Participates in marketing activities as assigned by the Marketing Team


  • Bachelor level degree in engineering or chemistry, physics, biology or related life science, advanced degree preferred
  • 2-5 years related work experience.
  • 1-3 years of experience in the medical device industry required
  • Consulting experience preferred


  • Working knowledge of FDA Quality System Regulations required
    • Understanding of Design Controls (Design inputs, Design outputs, Verification, Validation, Design Transfer)
    • Experience with DHF for electro-mechanical medical devices with embedded software, with Knowledge in:
      • Design input creation
      • Awareness of applicable standards for electro-mechanical devices with embedded software (IEC 60601, ISO 10993, BS/EN 62304, etc…)
      •  Ability to create a trace from design inputs to Verification and Validation.
      • Support the creation of DHF for world-wide distribution via regulatory agencies
  • Design Verification and Design Validation (Electro-mechanical devices w/ embedded Software)
    • Ability to create test procedures/protocols
    • Ability to oversee and execute testing
    • Ability to create test reports
  • Awareness of Safety and risk management per ISO 14971
  • Awareness of Usability per ISO 62366 and other Human Factors Standards
  • Knowledge of Manufacturing Process & Service Process
    • Process Validation (IQ/OQ/PQ)
    • In-line Verification Testing and Fixture qualification
    • Part Qualification
    • PFMEA
  • Computer skills required – Microsoft Office applications; statistical data analysis preferred
  • Report writing skills required
  • Must be willing to travel, up to 50%

Key Behaviors

Action-Oriented, Approachable, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning



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