Device Engineering Lead for Autoinjectors & Pens

Kailera Therapeutics; Boston (MA); On-site; USD 159,000 - 195,000; Full time

Benefits offered by this job

Health coverage

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Equity grants

Annual bonus opportunities

Job summary

Kailera Therapeutics, Inc. is seeking an experienced Associate Director of Device Engineering to steer development of drug‑device combinations, focusing on autoinjectors, pre‑filled syringes and multidose pens.

The role collaborates across CMC, quality, regulatory, manufacturing, clinical and commercial teams to meet patient needs and regulatory expectations. Required location is Waltham, MA with onsite presence 3–4 days per week.

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.
• Strong knowledge of design controls, verification/validation, risk management, human factors.

Responsibilities

• Lead development projects from concept to commercialization for device products.
• Create and manage project plans with risks and milestones.
• Define device requirements including user needs and verification protocols.
• Ensure compliance with FDA and ISO 13485 design controls.
• Oversee risk management per ISO 14971 and perform FMEA.
• Coordinate design transfer to manufacturing with cross‑functional inputs.

Skills

Leadership

Medical device development

Regulatory submissions

Cross-functional collaboration

Design controls

Risk management

Education

Bachelors in mechanical engineering

Biomedical Engineering

Advanced degree preferred

Job description

Kailera Therapeutics, Inc. is seeking an experienced Associate Director of Device Engineering to steer development of drug‑device combinations, focusing on autoinjectors, pre‑filled syringes and multidose pens.

The role collaborates across CMC, quality, regulatory, manufacturing, clinical and commercial teams to meet patient needs and regulatory expectations. Required location is Waltham, MA with onsite presence 3–4 days per week.