Senior Systems Engineer – Med Device Systems & Lifecycle

Amgen; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen in the United States is seeking a Senior Systems Engineer to lead development activities within a cross-functional program team for a device/biologic combination product, delivering system content, performance, and quality deliverables. You will translate user needs into system requirements, manage risk and verification, and maintain traceability and design documentation.

Regular collaboration with engineering, quality, regulatory, supply chain, and manufacturing ensures lifecycle changes

Qualifications

• Doctorate degree
• Master's degree + 2+ years of experience
• Bachelor's degree + 4+ years of experience
• Associate's degree + 8 years of experience
• High school diploma or GED + 10 years of experience
• 6+ years of progressive experience as an engineer

Responsibilities

• Lead development activities for a cross-functional program team to create technical content, performance, IP and quality deliverables for a combination product.
• Own systems engineering deliverables, ensure quality targets, identify risks and coordinate risk retirement activities.
• Maintain close cross-functional interaction across engineering, quality, regulatory, supply chain, packaging, labeling and product teams to manage lifecycle changes in a controlled manner.
• Lead requirements development and maintenance, including user needs, design inputs/outputs, and verification/validation planning.
• Mentor junior engineers and contribute to design reviews and issue resolution.

Job description

Amgen in the United States is seeking a Senior Systems Engineer to lead development activities within a cross-functional program team for a device/biologic combination product, delivering system content, performance, and quality deliverables. You will translate user needs into system requirements, manage risk and verification, and maintain traceability and design documentation.

Regular collaboration with engineering, quality, regulatory, supply chain, and manufacturing ensures lifecycle changes