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Kailera Therapeutics · 8 hours ago

Senior Scientist, Device Engineering

Greater Boston

Full-time

Hybrid

Senior Level, Lead/Staff

$115K/yr - $140K/yr

10+ years exp

Kailera Therapeutics is committed to developing therapies that empower individuals to improve their health. They are seeking a Senior Scientist in Device Engineering to lead the development and launch of drug-device combination products, focusing on autoinjectors and pre-filled syringes while ensuring compliance with regulatory standards.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Lead the design and development of combination products, including autoinjectors, pre-filled syringes, and multidose pens, from concept through commercialization

Develop device and combination product requirements including user and stakeholder needs, 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

Collaborate cross-functionally with clinical, regulatory, commercial, supply chain, and other key functions to ensure integration of 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), test vendors, and consultants to integrate deliverables into the project Design History File

Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, and IEC 62366

Qualification

Device developmentDesign controlsRisk managementRegulatory standardsAutoinjector developmentCross-functional collaborationSupplier managementLeadership skillsCommunication skillsProject management

Required

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

Deep understanding of design controls, risk management, human factors, and design transfer

Strong knowledge of applicable regulatory standards and guidance documents

Excellent communication, leadership, and cross-functional collaboration skills

Bachelor's degree in mechanical engineering, biomedical engineering, or related field with 12+ years of experience. Advanced degree with 10+ years of experience is preferred