Job Description

Senior Systems Engineer

About the role

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Smith and Nephew is seeking an experienced systems engineer to contribute to the creation of our latest products.

This position involves leading engineering activities for specific projects in order to meet business objectives. The systems engineer plays a crucial role in implementing and maintaining processes that support the successful development of medical devices. They are a technical leader with the necessary skills and knowledge to identify technical risks, question design choices, manage design history files, and bridge the gap between different parts of the product development process. Collaboration with Operations Personnel, Functional Managers, Senior Engineering, and Technical personnel is essential to ensure successful project delivery.

Responsibilities:

Take charge of leading the new product development process.

Define product requirements that align with customer needs, ensuring they are comprehensive, accurate, and present a challenging yet achievable target.

Generate system design concepts, evaluate and compare different design options, and select and implement the most suitable design.

Assess the performance of the system after implementation and ensure proper integration of the design.

Manage the design process and prepare documentation for the medical device\'s design history file, ensuring compliance with quality systems and relevant safety standards.

Monitor the project\'s budget, resources, and progress against milestones.

Ensure a smooth and efficient transfer of project implementation.

Collaborate with Project Management to develop and maintain project schedules.

Take the lead or co-lead in programs following the Strategic Product Definition Process.

Collaborate with the in-house legal department, external legal consultants, and Government Patent Officials as necessary for patent searches, infringements, and applications.

Requirements:

BS/MS in Engineering discipline, such as Biomedical, System, Electrical, and Software, or equivalent experience/skills.

Minimum of 5 years\' experience in a regulated industry, with recent experience in product registration and launch.

Technical role experience, specifically in systems engineering, encompassing design control, risk management, and quality management systems.

Familiarity with regulatory requirements for medical devices, including standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, YY/T 9706, REACH, and RoHS.

Demonstrated ability to plan and execute technical and engineering requirements for medical device product development, considering the entire system and user interaction.

Strong track record of creative problem-solving using tools, along with the tenacity and ability to overcome obstacles.

Clear evidence of scoping technical activities for regulated device development

Experience in Electrical Engineering for medical devices.

Proficiency in Analog/Digital circuit design and analysis using Altium or Orcad design software.

Knowledge and experience in Systems Architecture involving DSPs, Microcontrollers, and FPGAs.

Experience in Software/Firmware Engineering for medical devices.

Familiarity with programming languages such as C and C++.

Understanding of Object-Oriented Programming and Design patterns.

Experience with Embedded Linux development and familiarity with tools like Yocto for build systems, device trees, and shell scripts.

Experience in Human Factor Engineering for medical devices.

Competences:

Collaborate with users, sponsors, and stakeholders to understand their needs and strategically design and lead the development of medical devices that meet customer requirements.

Strong leadership skills demonstrated through leading cross-functional teams.

Track record of planning and delivering complex new products.

Ability to balance risk and business drivers, and provide robust and credible recommendations to the business that are subsequently endorsed and implemented.

Model and exhibit fully rounded critical success factors and positive behaviors across the organization.

Display good judgment in decision-making.

Familiarity with Regulatory requirements and Design Control for Medical Devices (510(k), CE MDD and MDR etc.)

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Smith & Nephew