Senior Device Development Lead, Combination Products

Scorpion Therapeutics; Boston (MA); Hybrid; USD 125,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Engineer/Manager for Device Development focused on combination products (autoinjectors, prefilled syringes, or wearable injectors). You will lead technical execution and program management, ensuring robust design controls and regulatory compliance.

The role requires 5–7 years in device development with expertise in ISO/FDA standards and SolidWorks. You will collaborate with Regulatory, Quality, CMC, and Clinical teams while supporting manufacturing

Qualifications

• BS/MS in Mechanical or Biomedical Engineering required.
• 5–7 years’ device development experience, especially for combination products (autoinjectors, prefilled syringes, or wearable injectors).
• Expertise in design controls, ISO standards, FDA regulations; proficiency in 3D modeling with SolidWorks.

Responsibilities

• Oversee device design control documentation and change control processes.
• Support human factors/usability engineering activities and CDMO tech transfers.
• Standardize platform components and manage external supplier relationships.
• Provide manufacturing support during clinical and commercial stages; ensure quality and regulatory compliance.
• Collaborate with Regulatory, Quality, CMC, and Clinical functions.

Skills

Design controls

Regulatory compliance

Cross-functional collaboration

Program management

Education

BS in Mechanical Engineering

MS in Biomedical Engineering

Tools

SolidWorks

Job description

Scorpion Therapeutics is seeking a Senior Engineer/Manager for Device Development focused on combination products (autoinjectors, prefilled syringes, or wearable injectors). You will lead technical execution and program management, ensuring robust design controls and regulatory compliance.

The role requires 5–7 years in device development with expertise in ISO/FDA standards and SolidWorks. You will collaborate with Regulatory, Quality, CMC, and Clinical teams while supporting manufacturing