Senior Manufacturing Engineer

Project Engineer

Job Location: St. Paul, MN

Division/Department: Engineering

Type of Position: Temporary to possible full-time hire

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