Associate Director, Device Development

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview
As an Associate Director, Device Development , you will lead the development and lifecycle management of drug–device combination products, with a focus on injectable delivery systems such as prefilled syringes and auto-injectors. You will serve as the device subject matter expert (SME), accountable for design control execution, design history file (DHF) ownership, and integration of device strategy across CMC, regulatory, clinical, and manufacturing functions.

This role operates at the intersection of device engineering, human factors, and pharmaceutical development, ensuring the delivery of safe, effective, and patient-centric drug delivery systems from late-stage development through commercialization.

Responsibilities and Duties

Device Development & Technical Execution

• Lead end-to-end development of combination products (e.g., prefilled syringes, auto-injectors) through commercialization
• Define and execute device strategy, including design, verification, validation, and lifecycle management
• Translate user needs into product requirements and executable development plans with defined milestones, timelines, and risk mitigation strategies
• Lead human factors activities and integrate patient/provider insights
• Identify and resolve device–drug interaction challenges

Quality, Risk & Regulatory

• Own Design History File (DHF) and ensure compliance and inspection readiness
• Serve as SME for design controls and risk management in accordance with 21 CFR Part 4/820, ISO 13485, ISO 14971, and IEC 62366
• Lead design controls, risk management (e.g., FMEA, hazard analysis), and change control
• Support regulatory submissions and health authority interactions
• Ensure compliance with global combination product regulations and standards
• Support audits, inspections, and quality system activities

Leadership, Operations & Partnerships

• Lead cross-functional teams across CMC, Regulatory, Quality, Clinical, and Supply Chain
• Manage external vendors, CDMOs, and development partners
• Provide technical support for manufacturing, tech transfer, and lifecycle management
• Communicate program status, risks, and decisions to stakeholders
• Manage timelines, deliverables, and continuous improvement efforts

 
Qualifications and Skills
Education & Experience

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline with 8+ years of relevant experience; advanced degree (MS or PhD) preferred
• Experience in combination product/device development (prefilled syringes and/or auto-injectors)
• Experience supporting late-stage development through commercialization

Technical Expertise

• Strong knowledge of design controls, DHF, risk management (ISO 14971), human factors (IEC 62366), and verification/validation
• Understanding of combination product regulations (e.g., 21 CFR Part 4, ISO 13485)
• Experience with injectable drug–device interfaces and biologics delivery systems preferred

Leadership & Execution

• Experience leading cross-functional teams in a matrixed environment
• Strong problem-solving, communication, and stakeholder influence skills
• Strong program management and ability to manage multiple priorities
• Experience managing vendors/CDMOs in regulated environments
• Commitment to quality, compliance, and ethical standards; willingness to travel (10–20%)

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.

More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm our core values are:

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success
• We value the unique contribution each individual brings to furthering our mission

Inherent in our core values is the commitment to act ethically and with integrity in all we do.

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.