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Senior Engineer - Regulatory (Contract Role)

Job Summary: The Senior Engineer applies their knowledge to the delivery of regulatory and quality solutions to enable client success. The Senior Engineer delivers work products and executes the defined consulting scope of work with minimal oversight by experienced consultants.

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

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

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

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 are 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

  • 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

Education/Work Experience

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science 
  • 5-10 years related work experience
  • 3-7 years of experience in the medical device industry required
  • Consulting experience preferred

Requirements

  • Working knowledge in one or more of the following areas is required:
  • Quality System Regulations (FDA, ISO13485, EU Medical Devices Directive, Canadian MDR)
  • Market Clearance and strategy (510K, EU Technical Files, Canadian licensing)
  • Design controls, DHF Development, and related standards especially International Electrical Safety, Biocompatibility, and ISO 10993 Software Development and Validation per EN 62304
  • Design Verification and Design Validation
  • Safety and risk management per ISO 14971
  • Usability per ISO 62366 and other Human Factors Standards
  • Process Validation
  • Computer skills required –Microsoft Office applications; statistical data analysis
  • Excellent 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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