Senior Device Technical Operations Engineer: Compliance

Scorpion Therapeutics; Pennsylvania; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Engineer in Device Technical Operations to oversee design transfer, process validation, and manufacturing support for complex medical devices and combination products such as autoinjectors, ophthalmic, and inhalation systems.

The role emphasizes design controls, risk management, and verification testing to ensure product robustness, regulatory compliance, and global technology transfer.

Qualifications

• Bachelor's in mechanical, biomedical, or related engineering field.
• At least 5 years’ experience in pharmaceutical, biologic, or medical device engineering, with 2+ years supporting commercial manufacturing.
• Proven skills in design controls, risk analysis, process validation, and manufacturing operations.
• Preference for autoinjectors or inhalation products; injection molding, automation, and complex assembly experience.

Responsibilities

• Leverage expertise in design controls, risk management, and verification testing to ensure product robustness and regulatory compliance.
• Support technology transfer globally, manufacturing issues, regulatory responses, and inspections.
• Foster internal and external strategic partnerships.

Skills

Design controls

Risk analysis

Process validation

Manufacturing operations

Injection molding

Automation

Complex assembly

Autoinjectors

Inhalation systems

Education

Bachelor's degree in mechanical/biomedical engineering

Job description

Scorpion Therapeutics is seeking a Senior Engineer in Device Technical Operations to oversee design transfer, process validation, and manufacturing support for complex medical devices and combination products such as autoinjectors, ophthalmic, and inhalation systems.

The role emphasizes design controls, risk management, and verification testing to ensure product robustness, regulatory compliance, and global technology transfer.