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Senior Manufacturing Engineer

2 months ago

St Paul MN United States SciPro Full time

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