Senior Engineer, Medical Devices – Sustaining & Quality

Stryker Corporation; Phoenix (AZ); Hybrid; USD 78,000 - 130,000; Full time

Benefits offered by this job

Travel 10%

Job summary

Stryker Corporation in Phoenix, AZ, is seeking a Senior Engineer in Product Engineering to lead sustaining projects for medical devices. You will investigate issues, implement design and process improvements, and work with Quality, Regulatory Affairs, Operations, and other teams to ensure product performance and compliance.

The role requires a Bachelor's in a engineering field and at least 2 years in a regulated setting, with knowledge of design controls, CAPA, and regulatory submissions.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related field.
• Minimum 2 years of engineering experience in a regulated industry.
• Experience with product investigations, design changes, validation activities, or quality improvements.
• Knowledge of medical device regulations and regulatory submissions.

Responsibilities

• Lead and support sustaining engineering projects for released medical devices, including design changes, line extensions, and product improvements.
• Investigate product, process, and packaging issues, identify root causes, and implement corrective and preventive actions.
• Coordinate design control, risk management, validation, and regulatory activities for product changes.
• Collaborate with cross-functional teams to support business objectives and drive quality and reliability.
• Apply statistical analysis to evaluate performance data and support technical decisions.

Skills

Statistical analysis

Regulated industry

Root cause analysis

Cross-functional collaboration

Education

Bachelor's in Mechanical Engineering

Tools

CAPA

Design controls

Validation protocols

Job description

Stryker Corporation in Phoenix, AZ, is seeking a Senior Engineer in Product Engineering to lead sustaining projects for medical devices. You will investigate issues, implement design and process improvements, and work with Quality, Regulatory Affairs, Operations, and other teams to ensure product performance and compliance.

The role requires a Bachelor's in a engineering field and at least 2 years in a regulated setting, with knowledge of design controls, CAPA, and regulatory submissions.