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