Senior Director, Device Engineering

Scholar Rock

. Serve as Scholar Rock’s technical lead and subject matter expert for combination products and drug delivery devices.

Posted 9/18/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $245,000 - $325,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in combination product and drug delivery device development, with a strong focus on regulatory compliance, design controls, and human factors engineering. Proven ability to lead cross-functional teams and manage complex projects from initiation through commercialization.

Highest-signal resume keywords

Combination Product DevelopmentDrug Delivery Device EngineeringRegulatory Compliance (FDA/EU)Human Factors EngineeringDesign Control Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Device User RequirementsDesign History FilesRisk ManagementVerification and ValidationSyringe FunctionalityInjection PerformanceBiologic Drug-Device IntegrationProject ManagementTechnical DocumentationUsability Studies

Soft Skills

LeadershipCommunicationCollaborationInfluencingStrategic Thinking

Tools & Technologies

Prefilled SyringesAutoinjectorsISO Medical Device StandardsEU MDRQuality System Requirements

Industry Keywords

Combination ProductDrug Delivery SystemsMedical Device DevelopmentEU Notified BodyCommercial Launch

About the role

Key responsibilities & impact

Serve as Scholar Rock’s technical lead and subject matter expert for combination products and drug delivery devices.
Provide hands-on technical leadership across development programs.
Lead device engineering activities for prefilled syringe, needle safety system, and autoinjector development programs.
Lead 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, EU technical documentation files, design control documentation, risk assessments, and supporting technical documentation.
Lead formative and summative human factors engineering and 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.
Provide technical leadership for device platform evaluation, selection, and lifecycle management.
Partner with and oversee external consultants, human factors vendors, device development partners, and contract test laboratories.
Develop scopes of work, manage budgets, and ensure outsourced device-related activities are executed successfully.
Support device-related investigations, change controls, commercial readiness, and post-approval lifecycle management.
Establish device engineering processes and best practices as the combination product portfolio grows.
Collaborate with Drug Product Development, Drug Product External Manufacturing, Regulatory CMC, Quality Control, and Quality Assurance.
Foster scientific rigor, innovation, collaboration, and continuous improvement.

Requirements

What you’ll need

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, with significant technical leadership responsibility for combination products.
Knowledge of ISO medical device standards 11608, 11040, 10993, 13485, and 14971; FDA/EU guidelines; 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, EU notified body technical documentation, risk management, design transfer, and verification and validation activities.
Experience with commercially available autoinjector vendors and platforms, such as Ypsomed, SHL, or similar platforms.
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.
Experience working with external consultants, vendors, and technical service providers.
Ability to work effectively in a highly collaborative, cross-functional environment and balance strategic leadership with hands-on technical execution.
Up to 20% travel as required.
Preferred experience: high-concentration biologics in prefilled syringe/autoinjector presentations; combination product regulatory approval and commercial launch; global biologics and combination product development; both prefilled syringe and autoinjector presentations; transition from intravenous to subcutaneous administration.

Benefits

Comp & perks

Full-time employment
Hybrid work arrangement
Up to 20% travel as required