Device Engineer

Responsibilities

• This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
• 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.
• Actively 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.
• Responsible for delivering 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
• Why You?
• We want people who care about patients and practical engineering outcomes. 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.

Requirements

• We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
• 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.
• 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

Benefits

Additional Information

Business Summary: We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary: You will join a cross-functional team designing and developing patient-focused delivery devices. You will lead technical assessments, prototype testing, and risk management while working closely with experts across engineering, formulation, quality, and supply. We value practical problem-solvers who are curious, collaborative, and focused on building safe, reliable, and manufacturable solutions. This role offers clear growth, the chance to shape next-generation device technologies, and meaningful impact aligned with our mission of uniting science, technology and talent to get ahead of disease together.

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Company Intel

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