Onsite Project Engineer, Medical Devices

VIVA USA INC

Plymouth (MN)

On-site

USD 100,000 - 135,000

Full time

6 days ago
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Job summary

VIVA USA INC. seeks a Project Engineer – Onsite with a strong background in medical devices and cross-functional leadership to independently drive sustaining engineering, supplier changes, and continuous improvement initiatives within Electrophysiology programs.

You will partner with R&D, Operations, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to plan, execute, and govern complex projects in line with client PM methodologies and FDA quality requirements.

Qualifications

  • Bachelor’s degree in engineering or related field.
  • Minimum 5 years of medical device experience in R&D, Manufacturing and/or Quality Engineering.
  • Excellent verbal and written communication with all levels including client suppliers and consultants.
  • Experience collaborating with cross-functional teams in a matrixed organization.
  • Demonstrated experience leading cross-functional projects or workstreams.
  • Ability to initiate, prioritize, and coordinate multiple tasks simultaneously.
  • Proficient in MS Word, Excel, PowerPoint, and Project.
  • Willingness to travel up to 10% domestically and/or internationally.

Responsibilities

  • Lead sustaining engineering, supplier change, and continuous improvement projects.
  • Coordinate projects per client PM methodologies and quality system requirements.
  • Manage scope, schedules, risks, deliverables, and stakeholder communications.
  • Drive cross-functional teams across R&D, Operations, Manufacturing, Quality, Regulatory, Supply Chain, and others.
  • Maintain project plans, risk registers, and action-item logs.
  • Develop dashboards, metrics, and leadership communications.
  • Support Change Orders, procurement coordination, and project reporting.
  • Utilize Windchill, SAP, Planview, Ariba for project execution and procurement.

Skills

medical device
R&D
Manufacturing
Quality Engineering
MS Word
Excel
PowerPoint
Project
Windchill
Product Lifecycle
SAP
ERP software
Planview
Ariba
COs
Documentation
supplier changes
design transfer
Lean
Six Sigma
Kaizen

Education

Bachelor’s degree in engineering or related field

Tools

Windchill
SAP
Planview
Ariba

Job description

VIVA USA INC. seeks a Project Engineer – Onsite with a strong background in medical devices and cross-functional leadership to independently drive sustaining engineering, supplier changes, and continuous improvement initiatives within Electrophysiology programs.

You will partner with R&D, Operations, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to plan, execute, and govern complex projects in line with client PM methodologies and FDA quality requirements.

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