Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. 

Great opportunity to help achieve Life Unlimited mission for our Smith+Nephew customers. Through this role, you will have a great exposure to a highly collaborative environment working on diverse engineering designs and supporting the testing of the Smith+Nephew Sports Medicine products. This role is dedicated to New Product Development initiatives and will act as a manager for system verification team members in Coimbra, Portugal.

What will you be doing?

Smith and Nephew seeks a R&D Manager I – Software Test Engineering in the Sports Medicine business to drive and lead system verification efforts in partnership with the Systems Engineering and R&D New Product Development teams. The role will work with the Senior R&D Manager of System Verification. The position will be based in Coimbra, PT.

Position Functions

Lead and coordinate test activities, schedule and resources, incident management and tracking.Autonomously lead large scale projects’ test activities, allocate test equipment and materials and align with Program Management and multi-functional on work you're doing and timelineAct as a domain expert (SME) in leading and supporting software test activities planning, execution and software test automation.Identify, report, track, prioritize HW/SW defects using defects management systems (e.g. JIRA) and validate fixesSupport the Systems engineers with definition of new products – implementing operational profiles, preparing for test, dry-run, performing test, tracing requirements to test cases and guiding the test strategySupport trouble shooting and root causing of Systems defects and enable R&D team identify fixesGuide verification plans, protocols, test cases, summary reports, trace matrix authoring and other related user documentation; Provide transparency to trace matrix test coverage and test progress for programsDirectly plan, develop and implement software testing (both manual and automated) for medical devices, based on context and risks associated with the projectPlan and coordinate testing with external test vendors, and generate adequate Scope of Work documentationParticipate in design and requirements reviews, analysis and support the development of documentation required for FDA device approvalSupport Software FMEA across various subsystems within the AET products, as per ISO 14971, IEC 62304, & IEC 80002-1Ensure the adequacy of software design quality for AET products, including test design, protocol and results review and other supporting quality evidenceSupport the Validation / qualification of third-party OEM products and internally developed software components and tools used for software development and verification/validation, including COTS/SOUP analysisCreate, validate, and maintain test automation platforms

What will you need to be successful?

Education:Bachelor of Science or equivalent experience/Engineering degree in Computer Engineering, Software Engineering, Electrical and Computer Engineering, or Biomedical Engineering with Software focus. Graduate degree or equivalent experience is highly preferred.Experience:BS in engineering or science + 5 years of related experience or MS in engineering or science field +3 year of related experienceA minimum of 2 years of experience in the medical device field or other highly regulated fieldA minimum of 2 years of experience in software development or software verification and validation

Strongly DesiredExperience in leading smaller teamsExperience in leading external test vendorsExperience in developing sophisticated products that includes hardware, electrical and softwareExperience with test strategy development and execution across a range of electromechanical products, including test automation, performance testing, negative testing, code and coverage analysis, and compatibility testingExperience with embedded software programming, application software programming of test automation & test frameworksExperience in software development and test processesSolid understanding of quality systems and quality assurance processes and principles, with a focus on development and/or verification/validation activitiesDetailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDD design control requirements for medical devices.Experience using JAMA/Cognition or similar tools for requirements managementHands-on experience in one or more of the programming or scripting languages (C/C++, C#. Java, Python, JavaScript, Linux/bash commands etc.)Hands-on experience in test automationPersistent, driven, self-motivated, keen to make an impactExcellent verbal and written communication skillsStrong problem solving and fixing skills

Travel requirements less than 10%

Hybrid role (2/3 times per week) Coimbra based

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website (https://www.smith-nephew.com/)Your Future: Generous annual bonus, Save As You Earn share options.Work/Life Balance: Meal allowance, Healthcare insurance, School Allowance, Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!Flexibility: Hybrid Working Model (For most professional roles).Training: Hands-On, Team-Customised, Mentorship.

Applications:

If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.

We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients.

We value the diversity of our people and welcome applications from everyone.

#li – ar2

#LI-Hybrid

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