Device Engineer

About the role

This role is offered as a hybrid position with on-site presence expected for laboratory work, prototype testing and key team activities. Occasional travel may be required.

Responsibilities

• Lead early device development activities from concept through feasibility and engineering confidence testing.
• Perform technology scouting and technical evaluations to identify suitable device solutions.
• Design, prototype, and run lab-based testing and simulations to verify device function, safety, and reliability.
• Identify and drive mitigation for technical, manufacturing and regulatory risks.
• Prepare and maintain core device documentation such as design history files, risk management files, and technical reports.
• Work with internal teams and external partners to support design for manufacturability and scale-up.
• Act as technical lead for the device ensuring Critical Process Parameters are identified, understood, monitored and controlled.
• Participate in the investigation team for device and equipment related issues. Lead quality investigations, RCA and CAPA associated with the device.
• Drive the improvement of unit operation process capability and batch yields. Specifically, be accountable for Cost of Goods and Cost of Waste improvements.
• Deliver key technical activities including NPI trials and planned change implementation.
• Lead/support development work in support of equipment installations and validation.
• Maintain a strong level of validation understanding and proficiencies within life cycle management, including expertise in design controls, manufacturing technologies and upcoming combination products for commercialization.
• Able to perform technical coaching of operators to ensure knowledge transfer to the manufacturing shop floor allowing operators to improve their accountability and timeliness of issue resolution.
• Lead/support risk management activities through the life cycle for devices and conduct periodic risk reviews based on ISO requirements.
• Create/Maintain Device History Files.
• Provide technical SME input for complaints related to the device.

Qualifications

• 3 + years of device or medical product experience with hands-on experience using CAD tools for device design and running prototype testing.
• Bachelor's degree in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering.
• Experience with design controls, risk management and quality processes used in medical device development.

Preferred Qualifications

• If you have the following characteristics, it would be a plus:
• Master’s degree in engineering or related field and additional device development experience.
• Experience with simulation tools (for example finite element analysis) and in-silico modelling.
• Experience in combination products or drug-device systems, including autoinjectors, pre-filled syringes, or on-body injectors.
• Familiarity with regulatory frameworks and standards relevant to device design, usability, and safety.
• Experience working with contract manufacturers, suppliers, or external partners on prototyping and scale-up.
• Hands-on skills in rapid prototyping, 3D printing, or mechanical test method development.
• Ability to coordinate multidisciplinary work and communicate technical results clearly.
• Proven record of managing multiple tasks and delivering to project timelines.