Senior Device Development Engineer - Autoinjector

About Us

About the Role

As the Senior Device Development Engineer, you will be the design and development engineering subject matter expert for our pre-filled syringes and directly impact user experiences, product quality and reliability.

Reporting to our Senior Director, Device Development you will lead and oversee ongoing development of our Accessorized Pre-filled Syringe (APFS) including creating and maintaining the design history file to align with design controls to support regulatory filing and product lifecycle management. You will work closely with internal cross-functional teams and oversee development vendors on a daily basis. You will lead the design, development and testing for our APFS and be involved in the ongoing development of our Autoinjector. You must have development engineering experience with prefilled syringes and/or autoinjectors in order to be successful in this role.

This is a highly visible role and will have significant impact on the overall success of bringing novel therapies to patients. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

Device Design and Development:

• Lead the design and development of autoinjectors, pre-filled syringes, and other parenteral drug delivery devices.
• Ensure that selection of materials, components and service providers results in a robust product design.
• Work closely with cross-functional teams, including mechanical engineering, materials science, and regulatory affairs, to ensure designs meet user needs and regulatory standards.

Prototyping and Testing:

• Develop and validate prototypes through rigorous testing and analysis.
• Conduct design verification and validation (V&V) studies, including performance testing, functional evaluations, and reliability analysis.

Project Management:

• Oversee project timelines, budgets, and deliverables to ensure successful device development.
• Collaborate with stakeholders to prioritize project goals and address technical challenges.

Regulatory Compliance and Documentation:

• Prepare and review technical documentation, including design history files, risk assessments, and usability engineering reports, in compliance with ISO 13485, ISO 11608, and FDA guidelines.
• Support regulatory submissions by providing technical expertise and data.

Supplier and Manufacturing Coordination:

• Partner with external suppliers to source components and ensure manufacturability.
• Assist in technology transfer to manufacturing teams, including process optimization and troubleshooting.

Experience

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum of 5–8 years of experience in medical device development, specifically with autoinjectors or pre-filled syringes
• Strong knowledge of design controls, risk management (21 CFR Part 4, ISO 14971, ISO 13485, ISO 11608, ISO 11040 and ISO 23908), and usability engineering principles.
• Hands-on experience with mechanical design tools (e.g., SolidWorks, Creo) and simulation software (e.g., FEA tools).
• Proven track record in device testing, including functional testing, reliability analysis, and usability studies.
• Familiarity with materials commonly used in drug delivery devices, such as plastics, elastomers, and metals.
• Comprehensive understanding of relevant regulatory requirements (FDA, ISO 11608, EMA).
• Design History File (DHF) experience.