Senior Quality Engineer, Medical Devices NPD

Regulatory Jobs; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards in Irvine, CA is seeking a strong engineer to support New Product Development with Quality Engineering leadership. You will apply design control and risk management principles across design verification, validation, and manufacturing specification development, partnering with cross‑functional teams to hit project milestones.

The role requires advanced degrees or equivalent, experience in Medical Device regulatory knowledge, and the ability to travel up to 20% domestically and

Qualifications

• Bachelor's Degree in Engineering or Scientific field with 4+ years' experience including either industry or industry/education
• Master's Degree or equivalent in Engineering or Scientific field with 3+ years' experience including either industry or industry/education
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

Responsibilities

• Provide technical leadership for successful new product development projects by applying design control and risk management principles to influence new product development efforts from concept through product launch including design verification, validation, and design/manufacturing specification development
• Partner and collaborate with cross-functional stakeholders to align on goals and drive actions to meet commitments
• Lead development and drive 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 mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
• Develop technical solutions to complex problems, recommend and implement corrective actions using statistical techniques and reliability engineering
• Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products
• Ensure compliance with all Federal, State, local and company regulations, policies and procedures
• Performs other incidental duties as assigned by management
• Ability to travel up to 20% domestically and internationally

Skills

Problem solving

Analytical thinking

Project management

Interpersonal skills

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

MS Project

Job description

Edwards in Irvine, CA is seeking a strong engineer to support New Product Development with Quality Engineering leadership. You will apply design control and risk management principles across design verification, validation, and manufacturing specification development, partnering with cross‑functional teams to hit project milestones.

The role requires advanced degrees or equivalent, experience in Medical Device regulatory knowledge, and the ability to travel up to 20% domestically and