Lead, Drug-Device Engineering for Subcutaneous Delivery

Scholar Rock; Cambridge (MA); On-site; USD 245,000 - 325,000; Full time

Job summary

Scholar Rock seeks an experienced Senior Director, Device Engineering to lead technical strategy for combination products and drug delivery devices. You will guide development from design controls through validation, ensuring medical device compliance across US and EU markets.

You will manage cross-functional teams, work with external vendors, and influence regulatory submissions while driving lifecycle management for a growing portfolio of subcutaneous presentations using prefilled syringes and

Qualifications

• Bachelor’s degree in Engineering or related field; advanced degree preferred.
• “15+ years” in combination product or medical device development with global experience.
• Knowledge of ISO medical device standards and regulatory expectations for combination products.

Responsibilities

• Serve as technical lead for combination products and drug delivery devices.
• Lead development programs for prefilled syringes, needle safety systems, and autoinjectors.
• Develop DHF/technical documentation, risk assessments, and verification/validation plans.
• Oversee design transfer, human factors engineering, and usability studies.
• Collaborate with Regulatory CMC, Quality, and External vendors.

Skills

Leadership

Drug-device integration

Design controls

Human factors usability

Regulatory submissions

Vendor management

Cross-functional collaboration

Project management

Communication

Travel readiness

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Ypsomed platform

Autoinjector platforms

EU MDR/ISO 13485 knowledge

Job description

Scholar Rock seeks an experienced Senior Director, Device Engineering to lead technical strategy for combination products and drug delivery devices. You will guide development from design controls through validation, ensuring medical device compliance across US and EU markets.

You will manage cross-functional teams, work with external vendors, and influence regulatory submissions while driving lifecycle management for a growing portfolio of subcutaneous presentations using prefilled syringes and