Project Engineering Manager

Reference Number: 470
Location: NC

Project Engineering Manager

This is a leadership role is on the Contract Manufacturing side of Medical Device which means that foundational skills will be tested in a variety of ways, almost every day and those competencies need to include an in-depth understanding of Process.  “Whether you’re interacting internally with peers, management or the shop floor or you are communicating with the client; Project Engineering represents the entire company, all the time.”  If you agree with that assertion, read on.   

As the leader of this team you will manage a group of engineers, coordinating projects, assigning resources, and assisting in the identification of new resource needs; participating in management of project scope, creep and change with a focus on client fulfillment and ensuring successful achievement of organizational and departmental goals.  “Flexible embracer of change, collaborator, team player, effective communicator and a strong advocate for the customer” are words/phrases the hiring manager uses to describe this person.  Is this you?

RESPONSIBILITIES: 

  1. Demonstrable skills participating on and leading cross-functional individuals and teams involved in the implementation of Device manufacturing from Development to Commercialization
  2. Uses a strong Engineering Aptitude in Medical Device manufacturing including Design Review, Material Specs, Assembly, Fixtures & Tooling, maintaining compliance to regulations, and QS’s
  3. Leads the team’s cross-departmental interactions ensuring accurate status and internal communication
  4. Interacts regularly with key customers in her/his sphere of influence at commercial and technical levels; maintaining strong relationships while adhering to contractual requirements
  5. Institutes accountability (KPI’s) managing resources to achieve goals, providing skills development and succession/growth opportunities for staff
  6. Hands-on technical leader providing guidance throughout the cycle for design, methods, process, quality and documentation as required
  7. Creates/maintains a culture of responsiveness and velocity, managing client expectations and meeting the employer’s targets for profitability
  8. Ensures appropriate focus on IP in the form of trade secrets, customer Agreements, innovation, recognition, etc. 

QUALIFICATIONS: 

  • Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial, or Biomedical preferred) with a minimum of 7 years’ experience where at least 2 of those are in a management/supervisory capacity
  • Experience in Medical Device Development and/or Manufacturing
  • Knowledgeable in the importance of adherence to the demands of a regulated environment, e.g. FDA and International Standards
  • Analytical and detail oriented with demonstrable Project Management skills but equally focused on results
  • Strong interpersonal skills, effective internally and externally; verbally and in written form
  • Effective leader who organizes, prioritizes multiple tasks and makes independent problem-solving decisions
  • Unafraid of a fast-paced environment where speed to market is a KPI internally and for the client
  • Computer skills should include the MS Office Suite, CAD (SolidWorks preferred) and tools like MiniTab
  • ISO 9001 and/or 13485 experience is preferred  
back to top