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Manufacturing Engineer

CONCORD IT SYSTEMS

Minneapolis, MN

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JOB DETAILS
SALARY
SKILLS
Agile Programming Methodologies, Best Practices, Bill of Materials (BOM), Calibration, Cleanroom, Code of Federal Regulations, Communication Skills, Computer Skills, Cross-Functional, Datasheets, Documentation, Drilling, ENOVIA, FDA (Food and Drug Administration), IBM Maximo Asset Management, ISO (International Organization for Standardization), Laboratory Equipment, Laboratory Testing, Manufacturing, Manufacturing Analysis, Manufacturing Engineering, Manufacturing/Industrial Processes, Materials Management, Microsoft Office, Microsoft Outlook, Minitab, Process Flow, Process Validation, Project/Program Management, Quality System Requirements (QSR), Regulations, SAP, Sterilization, Team Player, Technical Writing, Test Equipment, Windchill PLM Software
LOCATION
Minneapolis, MN
POSTED
3 days ago
Role: Manufacturing Engineer

Client : Medtronic/Tata Elxsi

Locations : Prefer in the greater Minneapolis area or in Santa Rosa locals

Rate : $50/Hr on C2C

Role and Responsibilities:

  • Collaborate on the project team and work under the direction of the Project Manager in a fast-paced environment supporting program initiatives and compliant with company best practices.
  • Familiar with Agile (Bill of Material & Drawing system) and BPCS (Materials management system).
  • Familiar with DHR/DMR/QSR, manufacturing process (drilling, milling, turning, assembly operations, cleaning operations, sterilization, Sealing process, Heat flow process, water resistant process etc.) and procedures.
  • Familiar with Safety Data Sheets/Consumables having PFAS.
  • Familiar with calibration process, lab testing equipment
  • Knowledge about PFAS, PTFE Materials, REACH Regulation
  • Inspect the machinery, equipment, and tools, analyse the manufacturing documents (DHR/WI/OP) to understand the indirect component to evaluate the potential impact by PFAS.
  • Working knowledge of manual and automated/semi-automated equipment.
  • Generate and revise Bills of Materials as applied to versioning.
  • Working under the guidance of the Senior and/or Principal Engineer.
  • The Manufacturing Engineer must be familiar with IQ/OQ/PQ (Installation Qualification / Operational Qualification / Performance Qualification) documentation and execution.
  • Conduct, coordinate, and aid in formal Process Validations including protocol development and execution.
  • Knowledge about pre-printed materials and labelling.
  • Co-ordination with Supplier quality and/or Material experts and status reporting to Project Manager
  • Excellent organization, Planning, Computer skills, technical writing, Communication skills. MS Office Suite and Outlook.
  • Dynamic team player and can work effectively and proactively on cross-functional teams
  • Prior experience as FTE engaged on the manufacturing floor (including cleanrooms)
  • The employee is also required to interact with a computer, and communicate with peers and co-workers
Must Have:

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have:
  • Audit Training (ISO 13485 and FDA 21CFR820 Training)
  • Tools:
    • AgileMap, CAP Agile, Enovia, Windchill.
    • SAP
    • SDS database (e.g Demarco, Sphera)
    • Minitab
    • Maximo
    • BPCS
  • Past Experience with Medtronic

About the Company

C

CONCORD IT SYSTEMS

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