Senior Director, Device Engineering

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures.

Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at and follow @Scholar Rock on X and on Linked In.

Scholar Rock is looking for an experienced Senior Director, Device Engineering to be the company’s technical subject matter expert for combination products and drug delivery devices. This is a hands‑on technical role, in which you will help shape and execute device engineering strategy for biologic assets, including the development of subcutaneous presentations using prefilled syringe (PFS) and autoinjector technologies, as well as drug delivery solutions for future pipeline assets.

You will lead key device development activities, including design controls, drug-device integration, assembly process development, characterization/validation, device risk analysis, design history file (DHF) management, verification and validation, design transfer and human factors engineering. You will also partner with Regulatory CMC on combination product regulatory activities and work closely with Drug Product Development, Drug Product External Manufacturing, Regulatory CMC, Quality Control, and Quality Assurance.

This role includes the opportunity to lead external consultants and device partners and support oversight of device testing at contract test laboratories.

• Serve as Scholar Rock’s technical lead and subject matter expert for combination products and drug delivery devices providing hands‑on technical leadership across development programs.
• Lead device engineering activities that support prefilled syringe, needle safety system and autoinjector development programs.
• Provide technical leadership for drug-device integration, including primary container/device interfaces, syringe functionality, injection performance, dose delivery, and other critical device performance attributes.
• Define and maintain device user requirements, design inputs, design outputs, traceability matrices, verification/validation plans and acceptance criteria.
• Develop and maintain design history files (DHF), EU technical documentation files, design control documentation, risk assessments, and supporting technical documentation.
• Lead human factors engineering activities, including formative and summative usability studies.
• Partner with Regulatory Affairs and Regulatory CMC on U.S. combination product requirements and EU device requirements, including EU MDR Article 117 and Notified Body Opinion activities, as applicable.
• Provide technical leadership for device platform evaluation, selection, and lifecycle management activities.
• Partner with and oversee external consultants, human factors vendors, and device development partners.
• Develop scopes of work, manage budgets, and help ensure outsourced device-related activities are executed successfully.
• Support device-related investigations, change controls, commercial readiness activities, and post-approval lifecycle management.
• Establish…