Associate Director, Device Engineering

Kailera Therapeutics; United States; Hybrid; USD 159,000 - 195,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus

Job summary

Kailera Therapeutics is seeking an experienced Associate Director, Device Engineering, to lead development and launch of drug-device products, emphasizing autoinjectors, pre-filled syringes, and multidose pens.

You will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust development aligned with patient needs and regulatory expectations.

Qualifications

• Minimum 10+ years in medical device or combination product development.
• At least 3 years in a team leadership role.
• Experience with autoinjector, pre-filled syringe, or multidose pen development and launch.
• Strong knowledge of FDA/ISO 13485 design controls, risk management, and design transfer.

Responsibilities

• Lead development projects from concept through commercialization for device/combination products.
• Develop and manage project plans with clear risks and milestones.
• Define device requirements including user needs and translate to verified/validated specs.
• Ensure compliance with FDA/ISO 13485 design controls and ISO 14971 risk management.
• Oversee human factors activities per FDA guidance and IEC 62366.
• Coordinate design transfer to manufacturing for scalable production.
• Collaborate with CMC, QA, Regulatory, Clinical, and Commercial teams.
• Prepare regulatory submissions (INDs, NDAs, BLAs) for devices.
• Manage vendor/CDMO relationships to meet quality/tech requirements.

Skills

Medical device development

Program leadership

Cross‑functional collaboration

Regulatory knowledge

Quality systems

Risk management

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Job description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do

We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities

• Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization
• Build and execute project plans with clearly defined risks and milestones
• Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements
• Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements
• Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies
• Drive design verification and validation activities, including test method development, protocol execution, and documentation
• Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366
• Facilitate design transfer to manufacturing, ensuring smooth transition and scalability
• Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities
• Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs
• Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing
• Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File
• Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366

Required Qualifications

• Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role
• Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions
• Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer
• Strong knowledge of applicable regulatory standards and guidance documents
• Excellent communication, leadership, and cross-functional collaboration skills

Preferred Qualifications

• Experience working in a regulated pharmaceutical or biotech environment
• Familiarity with combination product regulations (21 CFR Part 4)
• Experience with supplier management of external development, testing, and manufacturing partners
• PMP certification or formal project management training is a plus

Education

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred.

Salary Range

$159,000—$195,000 USD

For Full Time Roles:

This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

Equal Employment Opportunity Information

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, citizenship status, age, sex or gender, sexual orientation, marital status, military service, veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.