Sr Project Engineer
The Judge Group Inc.

Job Info

---

Location: Eagan, MN
Salary: TBD
Description:
Our Eagan, MN Medical Device client has an immediate need for a Project Engineer. In this role you will:

• Provide engineering expertise for:
  • Support of existing manufacturing operations
  • Improvement of existing medical disposable products
• Regular support of manufacturing operations including:
  • IQ/OQ/PQ activities
  • Risk management documentation
  • Process development and training
  • LEAN implementation
  • Other associated activities related to medical products manufacturing
• Essential Job Duties & Responsibilities:
  • Define and implement Verification and Validation activities.
  • Meet required schedules.
  • Facilitate project plans and reviews.
  • Facilitate risk analysis and implement solutions to mitigate identified risks.
  • Design manufacturing jigs, fixtures, and equipment.
  • Write work instructions.
  • Create internal label specifications.
  • Process document change orders (DCO's) promptly, accurately, and completely.
  • Support manufacturing to produce products meeting Summit Medical quality standards, cost targets, and production schedules.
  • Develop processes that are safe, mistake-proofed, and have easy-to-follow instructions using design for manufacturing principles.
  • Support purchasing with complete documentation as required. Source, visit, and qualify vendors.
  • Perform failure analysis, complete corrective actions, and preventative actions as needed to support quality.
  • Provide cost and expense information as required to accounting.
  • Perform other duties as assigned by the manager.
• Education & Experience Requirement:
  • Bachelor's Degree in Manufacturing or Process Engineering OR equivalent work experience.
  • Medical device experience.
  • Software proficiency: Microsoft Word, Excel, PowerPoint, Project, Solidworks, Minitab.
  • Manufacturing process knowledge including:
    • Lean Manufacturing.
    • Packaging and labeling.
    • Cleanroom and sterilization processes.
  • Experience with small to large semi-automated equipment implementation including:
    • Working with outside equipment manufacturers for quotes.
    • Design inputs.
    • Validations (FAT, SAT, IQ, OQ, PQ).
  • Materials selection knowledge including physical properties and biocompatibility (ISO10993).
  • Product Design knowledge design for manufacturing, and drafting standards.
  • FDA and ISO design control regulations.
• Preferred Skills & Abilities:
• Possess excellent verbal and written communication skills and organizational skills.
• Mechanical aptitude with the capability to install, assemble, repair, and maintain production equipment.

Apply here or reach out to me directly! jtooker@judge.com

Contact: eweber@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.