Senior Quality Engineer — Medical Device NPD & Design Controls

Edwards Lifesciences Gruppe; United States; On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a strong engineer to join the IHFM team in the United States. You will provide technical leadership for new product development, applying design controls and risk management from concept through product launch.

You will collaborate with cross-functional stakeholders, lead test method development and validation, and drive robustness in design and manufacturing transfer. Domestic and international travel up to 20% is required.

Qualifications

• Bachelor's degree in Engineering or Scientific field required.
• Master's degree or equivalent in Engineering or Scientific field with 3+ years of experience.
• Ph.D. or equivalent in Engineering or Scientific field with industry experience.

Responsibilities

• Provide technical leadership for new product development projects from concept through launch.
• Collaborate with cross-functional stakeholders to align goals and drive actions.
• Lead development and updates to risk management files for new products.
• Lead test method development and validation activities for new designs.
• Lead development and implementation of inspection and testing mechanisms for components and assemblies.
• Develop technical solutions using statistics and reliability methods.
• Collaborate with manufacturing and operations to transfer and launch robust products.
• Ensure compliance with regulations, policies and procedures.
• Travel up to 20% domestically and internationally.

Skills

Design Controls

Risk Management

New Product Development

Quality Engineering

Test Method Development

Statistical Methods

MS Project

Cross-functional Collaboration

Education

Bachelor's degree in Engineering or Scientific field

Master's degree or equivalent

PhD or equivalent

Tools

MS Project

Job description

Edwards Lifesciences is seeking a strong engineer to join the IHFM team in the United States. You will provide technical leadership for new product development, applying design controls and risk management from concept through product launch.

You will collaborate with cross-functional stakeholders, lead test method development and validation, and drive robustness in design and manufacturing transfer. Domestic and international travel up to 20% is required.