Description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. 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

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.

Associate Director, Device Development

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