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Regulatory and Quality Project Engineer

Job Summary:  The Senior Principal Engineer is becoming a recognized industry technical expert and serves as a subject matter expert and mentor for staff and the senior technical interface for clients. The Senior Principal Engineer transforms both R&Q and the client’s business by ensuring the delivery of regulatory and quality solutions that are best practice and innovative to enable client success through delivery of superior service either individually or by leading a team. The Senior Principal engineer is able to lead programs for R&Q.

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

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

  • Leads daily regulatory and quality hands-on support to clients by providing best practice and innovative solutions.
  • Leads in the drafting of complex worldwide regulatory strategies and worldwide regulatory submissions
  • Creates the development of complex Master Validation Plans using risk based approaches; leads subsequent process validation activities
  • Leads manufacturing site transfers both nationally and internationally
  • Leads Quality System Development programs as well as Quality System Improvement programs
  • Leads quality audits and audit preparation of clients
  • Leads design assurance activities: safety risk management, usability, design verification and design validation
  • Leads FDA mock audits
  • Leads acquisition due diligence activities for mergers and acquisition activities
  • Leads and provides input to guidance document committees (FDA, etc.) both in the development and interpretation of the documents
  • Leads in the definition of supplier quality specifications and other supplier qualification activities
  • Leads supplier audits
  • Leads post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities as directed by an experience consultant
  • Leads recall decision making and all associated recall activities
  • Completes an effective independent review of deliverables as assigned
  • Leads a small group of team members to ensure their growth and development based upon the     team member’s goals while balancing the business' needs
  • Leads people with a high level of emotional intelligence
  • Advocates for their team members with regard to project performance issues and concerns
  • Ensures team members are fully communicated with in regards to important R&Q activities and have a conduit to share issues, concerns, process improvements, etc.

Project Leadership

  • Leads increasingly complicated projects in accordance with the R&Q QMS Project Management Procedure
  • Ensures all projects are on schedule and hitting cost targets, profit margin, and in compliance with the R&Q Quality Management System
  • Once the Business Development activity is complete (Contract signed), leads the customer to closure on the first project as well as pursues additional projects with the clients
  • Leads projects to ensure the customer is 100% satisfied with the project, fully communicated with, and that any issues are predicted prior to them actually arising.  Must be able to understand the customer satisfaction level of the project at any given time

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 risks and issues to the project lead in a timely fashion

Sales and Marketing

  • Selects 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 strong medical device industry network to provide connections to the Sales Team
  • Participates in marketing activities as assigned by the Marketing Team

Education

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science, advanced degree preferred
    10-15 years related work experience.
    7-10 years of experience in the medical device industry required
    Consulting experience preferred

Requirements

 

  • Expert knowledge in three or more of the following areas and general knowledge of all areas is required:
  • Quality System Regulations (FDA, ISO13485, EU Medical Devices Directive, Canadian MDR)
    • Expert understanding of Design Controls
  • Market Clearance and strategy (510K, EU Technical Files, Canadian licensing)
  • Experience in creating and remediating DHF for electro-mechanical medical devices with embedded software, with expertise in:
    • Design input creation via new product development process and/or re-creation during DHF remediation
    • Strong understanding of applicable standards for electro-mechanical devices with embedded software (IEC 60601, ISO 10993, BS/EN 62304, etc…)
    •  Incorporating Safety Risk Management and Usability into the product development process
    • Strong ability to create a trace from design inputs to Verification and Validation.
    • Identification and Traceability
    • Integration of Labeling
    • 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
  • Safety and risk management per ISO 14971
  • Usability per ISO 62366 and other Human Factors Standards
  • 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
  • Expert audit and 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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