Lead DPI Inhalation Device Systems Engineer

Amgen; Cambridge (MA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Discretionary annual bonus program

Retirement and Savings Plan

Job summary

Amgen is seeking a Sr. Engineer to lead the combination product inhalation device program. You will drive systems engineering and device development for dry powder inhaler platforms, ensuring robust design controls and integration with drug product and capsule interfaces.

You will own DHF/DDP deliverables, manage risk and verification strategies, and coordinate with regulators, suppliers, and cross-functional teams to support lifecycle changes and regulatory submissions.

Qualifications

• Doctorate degree required or equivalent combination of education and experience.
• Master’s degree with 2+ years of engineering experience or
• Bachelor’s degree with 4+ years of engineering experience or
• Associate’s degree with 8+ years of engineering experience or
• High school diploma / GED with 10+ years of engineering experience.

Responsibilities

• Lead DPI programs' systems engineering and device development, including architecture, needs & requirements, interfaces, and design reviews.
• Own Design History File (DHF) and Design and Development Plan (DDP) deliverables for the DPI device.
• Establish end-to-end traceability from user needs to verification activities and evidence.
• Develop verification strategy for DPI device and integrated product, including supplier evidence and bridging.
• Lead integration of supplier DPI platforms, assess evidence, and oversee device suppliers and lifecycle changes.
• Coordinate with regulatory, quality, drug product, analytical, manufacturing, clinical, human factors, and other teams for decisions and submissions.

Education

Doctorate degree

Master’s degree and 2 years of Engineering experience

Bachelor’s degree and 4 years of Engineering experience

Associate’s degree and 8 years of Engineering experience

High school diploma / GED and 10 years of Engineering experience

Job description

Amgen is seeking a Sr. Engineer to lead the combination product inhalation device program. You will drive systems engineering and device development for dry powder inhaler platforms, ensuring robust design controls and integration with drug product and capsule interfaces.

You will own DHF/DDP deliverables, manage risk and verification strategies, and coordinate with regulators, suppliers, and cross-functional teams to support lifecycle changes and regulatory submissions.