Senior Medical Device Systems Verification Engineer (Onsite)

Swoon

Plymouth (MN)

On-site

USD 137,760,000 - 148,781,000

Full time

2 days ago
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Job summary

Swoon in Plymouth, MN seeks a Senior Systems Verification Engineer for medical devices. This 12-month contract role is hands-on and focused on verification and validation of complex electromechanical systems to meet patient safety and regulatory requirements.

You will design test strategies, execute system- and hardware-level tests, analyze data with DOE, ANOVA, and capability analysis, investigate failures, and collaborate with cross-functional teams to ensure product quality.

Qualifications

  • Bachelor's in Engineering with 4+ years experience or advanced degree with 2+ years.
  • Ability to work 100% onsite in Plymouth, MN.

Responsibilities

  • Develop, execute, and document system-level and hardware-level verification and validation testing for complex medical devices.
  • Create and maintain test plans, verification protocols, technical reports, requirements traceability matrices, and risk assessments.
  • Perform hands-on testing of electromechanical systems integrating hardware, software, sensors, and mechanical components.
  • Apply statistical methods such as Design of Experiments (DOE), ANOVA, capability analysis, and sample-size determination to evaluate product performance.
  • Investigate test failures, perform root cause analysis, and collaborate with engineering teams to resolve product defects.
  • Develop and validate test methods to ensure accurate, repeatable, and reliable testing results.
  • Support requirements verification, risk-based testing, and regulatory compliance.
  • Identify opportunities to improve testing efficiency through automation, simulation, and alternative verification approaches.
  • Collaborate with cross-functional engineering, quality, and product development teams.

Skills

Systems verification
Medical device testing
Electromechanical systems
DOE
ANOVA
Capability analysis
Sampling methodologies
Requirements management tools
Minitab
MATLAB
Python
R
Root cause analysis
Agile

Education

Bachelor's degree in Engineering
Advanced Engineering degree

Tools

DOORS
Jama Connect
Polarion
Codebeamer
OpenText ALM

Job description

Swoon in Plymouth, MN seeks a Senior Systems Verification Engineer for medical devices. This 12-month contract role is hands-on and focused on verification and validation of complex electromechanical systems to meet patient safety and regulatory requirements.

You will design test strategies, execute system- and hardware-level tests, analyze data with DOE, ANOVA, and capability analysis, investigate failures, and collaborate with cross-functional teams to ensure product quality.

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