Senior Engineer/Manager, Device Development — 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

Role: Senior Engineer/Manager, Device Development - Combination Products

leading technical execution and program management for autoinjectors, prefilled syringes, or wearable injectors within biopharma drug development pipelines.

Responsibilities

overseeing device design control documentation, supporting human factors/usability engineering activities, standardizing platform components, and managing external supplier relationships and technology transfers. The role also involves providing manufacturing support during clinical and commercial phases, ensuring quality and compliance, and collaborating with cross-functional teams (Regulatory, Quality, CMC, Clinical).

Qualifications

• BS/MS in Mechanical, Biomedical Engineering
• 5-7 years’ experience in device development, especially for combination products like autoinjectors or prefilled syringes
• expertise in design controls, ISO standards, FDA regulations, and 3D modeling (SolidWorks)

Preferred

• experience with human factors studies, program lifecycle management, and biologic injectables
• prior manufacturing site support

HighValue

• biologics, combination devices, clinical and commercial manufacturing, regulatory documentation, cross-functional collaboration, international travel (~20-30%).

WorkSetup

Hybrid Waltham, MA with travel.