Senior Engineer, Device Technical Operations (Hybrid)

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

Role

Senior Engineer in Device Technical Operations overseeing design transfer, process validation, and manufacturing support for complex medical devices and combination products such as autoinjectors, ophthalmic, and inhalation systems.

Responsibilities

Responsibilities include leveraging expertise in design controls, risk management, and verification testing to ensure product robustness, regulatory compliance, and successful technology transfer globally; supporting manufacturing issues, regulatory responses, and inspections; and fostering internal and external strategic partnerships.

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, especially in injection molding, automation, and complex assembly for medical devices, with preference for autoinjectors or inhalation products

High-value specifics

Focus on combination products with regulatory and lifecycle management responsibilities, supporting global commercialization, and ensuring compliance with ISO 13485 and ISO 14971 standards.

Work setup

Hybrid in the US with approximately 10% travel; role emphasizes collaboration with manufacturing, R&D, and regulatory teams to drive product quality and compliance.