Project Engineer

Reference Number: 467
Location: NC

Project Engineer

 “Whether you’re interacting internally with peers, management or the shop floor or you are communicating with the client; as a Project Engineer you are representing the entire company, all the time.”  If you agree with that assertion, read on.    Project engineering or management has its foundation in an in-depth understanding of Process.  This role is on the Contract Manufacturing side of Medical Device which means that foundational skill will be tested in a variety of ways, almost every day. 

You might be a EE looking for their next challenge because this company does some high end capital assembly.  Or, you may an experienced Packaging Engineer because they handle tens of millions of sterilized packages every year; you see, it’s a Contract Manufacturer so they aren’t interested in pigeonholing you.  What other characteristics do you need to exhibit?  Flexibility, embracer of change, collaborator, team player, effective communicator and a strong sense of the customer’s importance to the company’s success. 

RESPONSIBILITIES: 

  1. Demonstrable skills participating on and leading cross-functional teams involved in the implementation of Device manufacturing from Development to Commercialization
  2. Uses a strong Engineering Aptitude in the many stages of Medical Device manufacturing including Design Review, Material Specs, Assembly, Fixtures & Tooling, and Packaging ensuring the maintenance of all the documentation required for compliance to Federal & International regulations, as well as the Client’s and Internal QS
  3. Communicates regularly with key customers in her/his sphere of influence at commercial and technical levels; maintaining a strong relationship between the employer and the client while adhering to contractual requirements as specified by FDA and ISO
  4. Leads, performs and documents the various activities of V&V including protocols, process validation, capabilities studies, and DOE’s
  5. Ensure the accuracy and clarity of project documentation from drawings to planning and implementation (e.g. SOP’s and Work/Assembly Instructions) ensuring projects are coordinated with manager and status accurately reported to management
  6. May lead Capital Equipment acquisition/justification activities as well as be involved with the IQ/OQ components of their implementation
  7. Provides the necessary guidance and recommendations to ensure regulatory compliance, e.g. V&V and Statistical Models, is met
  8. Participates in VOC activities at both the end user and with suppliers
  9. Participates as a key member of the Estimating Team with manager and Sales, assisting in definition of costs (i.e. quoting) and scope for project proposals 
  10. A willing and effective communicator capable verbally or in writing in interactions in-house, with vendors and especially with customers 

QUALIFICATIONS: 

  • Bachelor’s degree in Engineering (mechanical, industrial, packaging or electrical), a minimum of 3 years’ in Medical Device manufacturing/assembly with at least one year of experience in project engineering
  • Demonstrable technical aptitude exhibiting broad-based experience as described above
  • Collaborative personality style, skilled in a team-based organization
  • Confident, fact-based decision-making skills
  • Analytical and root cause focused in problem-solving
  • Project management, organizational, and time management skills
  • Skilled in the use of the Microsoft Office Suite, SolidWorks and preferable experience in statistical software like MiniTab
  • Understands how to ensure compliance from experience with ISO9000 or ISO13485 
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