Project Engineer
Job Location: St. Paul, MN
Division/Department: Engineering
Type of Position: Temporary to possible full-time hire
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Job Summary
Provide engineering expertise for the support of existing manufacturing operations and improvements of existing medical disposable products. Regular support of manufacturing operations including IQ/OQ/PQ activities, risk management documentation, process development and training, LEAN implementation, and other associated activities related to medical products manufacturing.
Essential Duties and Responsibilities
- Define and implement Verification and Validation activities.
- Adapt machine or equipment design to factory and production conditions.
- Facilitate project plans and reviews
- Facilitate risk analysis and implements solutions to mitigate identified risks.
- Will design manufacturing jigs, fixtures and equipment
- Develop manufacturing processes that are applicable to statistical process control, and may develop those techniques
- Create internal label specifications
- Inspect performance of equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
- Support manufacturing, helping to produce products meeting quality standards, cost targets, and production schedules.
- Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
- 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
- Provides cost and expense information as required to accounting.
- Other duties as assigned by manager
Experience & Education Requirements
- Bachelor's Degree in Engineering OR equivalent
- 3-5 yrs. medical device experience preferred
- Program Management
- Software proficiency
- Microsoft Word, Excel, PowerPoint, Project, Solidworks, Minitab.
- Manufacturing process knowledge including:
- Lean Manufacturing.
- Packaging and labeling.
- Automation selection preferred
- 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
- Possess excellent verbal and written communication skills and organizational skills while managing multiple priorities, often under deadlines.
**This position is not eligible for a relocation package**
Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).
EOE/Disabled/Veteran