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HLT Medical

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Sr. Design Assurance Engineer



Quality

Maple Grove, MN
 • 
ID: 935-432
 • 
Full-Time/Regular

Lead product design verification activities by interpreting standards, creating a top-level verification strategy, organizing the execution of that strategy, executing test plans to generate data, and generate risk analysis documentation.  Create inspection documentation for incoming materials, in-process subassemblies and finished products. As required, assist with investigations related to nonconforming materials and products, CAPAs and customer feedback. 

Primary Duties and Responsibilities:

Duty/Responsibility

 

Design Verification Activities 25%

  • Use applicable standards to generate design verification strategies. 
  • Analyze test data using standard statistical techniques.
  • Write clear and detailed test protocols and reports.

Risk Analysis 25%

  • Generate risk analysis documents such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis for generation of a risk management report.

Material Management 25%

  • Generate inspection procedures for incoming components, in-process subassemblies and finished product.

Document Review 15%

  • As required, review manufacturing documentation for suitability, specifically with regards to defined risks.

Other Responsibilities 10%

  • Manage traceability of design features to verification and risks to mitigation
  • Execute process validation activities
  • Represent the Design Assurance function on a project core team level.

Required Skills

Requirements & Qualifications (Knowledge, Skills & Abilities): 

Minimum:

  • Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by HLT Medical.
  • BA/BS in Engineering or Science related field.
  • 5+ years of medical device experience.
  • Experience with statistical methods and terminology.
  • Effective oral and written communication skills.
  • Demonstrated organizational and administrative skills.
  • Ability to prioritize and complete multiple tasks.
  • Demonstrated problem-solving skills

Preferred:

  • 5-10 years’ experience as a quality/design assurance engineer in a medical device environment
  • Experience with Nitinol, tissue, or heart valves

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