Senior Medical Device Product Engineer – Hybrid

Stryker; Tempe (AZ); Híbrido; USD 78.000 - 130.000; Jornada completa

Descripción de la vacante

Stryker's Sustainability Solutions team in Tempe, AZ, is seeking a Senior Engineer for Product Engineering to drive design changes, verify and validate devices, and support regulatory compliance across the product lifecycle.

You will collaborate with design, quality, regulatory, and manufacturing teams to address technical challenges, investigate issues, and enable product improvements while leveraging statistical methods and testing. Hybrid work requires onsite several days a week.

Formación

• Bachelor's degree in an engineering discipline required.
• Minimum 2 years of engineering experience in a regulated industry.
• Experience with product investigations, design changes, validation activities, or quality improvement initiatives.

Responsabilidades

• Lead engineering activities for new and existing medical devices, including product improvements and line extensions.
• Manage design control activities, risk assessments, and regulatory documentation to maintain FDA compliance.
• Investigate product and packaging failures, identify root causes, and implement corrective actions.
• Support customer complaint investigations by partnering with Quality and Manufacturing to resolve issues.
• Plan and execute engineering research, design, development, verification, and validation activities.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, Marketing, and suppliers to support development and manufacturing improvements.
• Apply statistical analysis and testing methods to evaluate performance and support decisions.
• Drive continuous improvement to enhance product quality and manufacturing efficiency.

Conocimientos

Regulated industry experience

Design controls

Quality improvement

Educación

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field

Herramientas

SolidWorks

Descripción del empleo

Stryker's Sustainability Solutions team in Tempe, AZ, is seeking a Senior Engineer for Product Engineering to drive design changes, verify and validate devices, and support regulatory compliance across the product lifecycle.

You will collaborate with design, quality, regulatory, and manufacturing teams to address technical challenges, investigate issues, and enable product improvements while leveraging statistical methods and testing. Hybrid work requires onsite several days a week.