Lead DPI Device Engineer — Combination Product Systems

BioSpace; Cambridge (MA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Sr. Engineer to lead the design and development of inhalation device combinations.

You will own system architecture, needs and requirements engineering, and interface definitions for dry powder inhaler programs, ensuring robust documentation and traceability across DHF and DD P processes. You will partner with regulatory, quality, manufacturing, analytical and clinical teams to bridge supplier evidence, assess platform knowledge, and drive device performance through

Qualifications

• Must have strong design-control experience in medical devices.
• Experience with needs/requirements engineering and risk controls.
• Ability to manage DHF and DD P deliverables end-to-end.
• Experience leading cross-functional device-development programs.

Responsibilities

• Lead DPI program systems engineering and device development.
• Own DHF/DDP deliverables and ensure design-control documentation.
• Establish end-to-end traceability from user needs to verification evidence.
• Develop verification strategy including supplier evidence bridging.
• Provide technical oversight of device suppliers and risk management.
• Coordinate with regulatory, quality, manufacturing, and clinical teams.

Skills

Systems engineering

Device development

Design controls

Requirements engineering

Education

Doctorate degree

Masters degree + 2 years engineering

Bachelors degree + 4 years engineering

Associates degree + 8 years engineering

High school diploma / GED + 10 years engineering

Job description

Amgen is seeking a Sr. Engineer to lead the design and development of inhalation device combinations.

You will own system architecture, needs and requirements engineering, and interface definitions for dry powder inhaler programs, ensuring robust documentation and traceability across DHF and DD P processes. You will partner with regulatory, quality, manufacturing, analytical and clinical teams to bridge supplier evidence, assess platform knowledge, and drive device performance through