Senior Director, Device Engineering

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 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 ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

Summary of Position:

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.

Position Responsibilities

• 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 fit-for-purpose device engineering processes and best practices as Scholar Rock’s combination product portfolio grows.
• Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement.

Candidate Requirements

• A bachelor’s degree in Engineering, Life Sciences, or a related discipline; an advanced degree is preferred.
• 15+ years of experience in combination product, drug delivery device, or medical device development for the US and EU; global experience is a plus, with significant technical leadership responsibility for combination products
• Knowledge of ISO medical device standards (11608, 11040, 10993, 13485, and 14971), FDA/EU guidelines, and global regulatory expectations for commercializing combination products, including FDA combination product requirements, 21 CFR Part 4, applicable Quality System requirements, and EU MDR Article 117.
• Experience with prefilled syringes, autoinjectors, and injectable drug delivery systems from project initiation through commercialization and post-approval lifecycle management.
• Experience with biologic drug-device integration, including primary container/device interfaces and functional performance of prefilled syringe systems.
• Hands-on experience with design controls, design history files (DHF), EU notified body technical documentation, risk management, design transfer, and verification and validation activities.
• Experience with commercially available autoinjector vendors and platforms (e.g., Ypsomed, SHL, or similar platforms) and demonstrated experience evaluating, selecting, and developing platform-based autoinjectors.
• Experience leading human factors engineering programs and usability studies, including development of human factors strategy
• Experience authoring and reviewing technical documentation supporting regulatory submissions.
• Strong leadership, communication, project management, and influencing skills, with experience working with external consultants, vendors, and technical service providers.
• The ability to work effectively in a highly collaborative, cross-functional environment and to balance strategic leadership with hands-on technical execution.
• Up to 20% travel as required.

Preferred Experience

• Experience developing high-concentration biologics in prefilled syringe and/or autoinjector presentations.
• Experience taking at least one combination product through regulatory approval and commercial launch.
• Experience with biologics and combination product development globally, including the US, EU, and rest-of-world markets.
• Experience with both prefilled syringe and autoinjector presentations, including progression from healthcare-professional-administered to patient/caregiver-administered products.
• Experience supporting transition of products from intravenous to subcutaneous administration.

$245,000 - $325,000 a year

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .