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The Position

An exciting opportunity has become available within the System Development and Integration team at our site in Motherwell Scotland. Working as a Senior Development Engineer you will be responsible for supporting the Cobas Lumira platform through the management of configuration requirements and risk across the product lifecycle.

Key responsibilities:

• Permanently optimizes processes in order to increase quality and efficiency standards.

• Ensure compliance to regulations relating to safety health and the environment (SHE) general Roche guidelines and regulations by law

• Configuration Management:

  • Establish and maintain configuration management processes and procedures to control product configurations including hardware software and documentation.

  • Manage and track configuration items in a configuration management database (CMDB) to ensure accurate and uptodate records.

  • Collaborate with crossfunctional teams to ensure changes are properly documented reviewed and implemented in a controlled manner.

  • Define and manage product baselines at various stages of the product lifecycle ensuring that baseline configurations are accurately maintained and communicated.

  • Oversee version control processes for all configuration items including software releases hardware revisions interface specifications and documentation updates.

  • Ensure proper labeling storage and retrieval of all configuration items and their associated versions.

  • Maintain comprehensive configuration management documentation including configuration plans procedures and records.

  • Communicate impact assessment of proposed configuration changes to stakeholders.

• Requirements Management:

  • Collate and analyse stakeholder requirements obtained through crossfunctional processes.

  • Develop a clear understanding of customer needs clinical workflows and regulatory requirements to inform product specifications.

  • Create and maintain comprehensive requirements documentation including user requirements system requirements and detailed specifications.

  • Establish and maintain a requirements traceability matrix to track the relationships between requirements design implementation risks and verification.

  • Collaborate with the testing and quality assurance teams to develop verification and validation plans test protocols and configuration control of test cases that ensure requirements are met.

  • Manage requirements changes through a structured change control process including impact analysis and stakeholder communication.

• Risk Management:

  • Conduct and coordinate thorough risk assessments to identify potential hazards associated with the design development and use of medical devices.

  • Perform qualitative and quantitative risk analyses to evaluate the likelihood severity and impact of identified risks.

  • Develop and implement risk mitigation strategies and controls to minimize identified risks to acceptable levels.

  • Collaborate with crossfunctional teams to incorporate risk control measures into design manufacturing and postmarket processes.

  • Create and maintain comprehensive risk management plans in accordance with regulatory standards (e.g. ISO 14971.

  • Ensure that risk management activities are integrated into the overall product development process.

  • Maintain detailed and accurate records of risk assessments risk control measures and risk management activities.

Additional tasks:

• Coordinate crossfunctional teams as necessary to achieve specific shortterm goals

• Responsible for ensuring required trainings are uptodate

• Support of team members in achieving overall goals

• Working in an agile framework to continuously improve efficiency and quality of work

Who you are:

• You have a Bachelors degree in Engineering Computer Science or a related field

• You have excellent organizational skills and attention to detail

• You have strong analytical and problemsolving skills

• You have experience in data processing and analysis

• You have effective written and verbal communication as well as collaboration skills

Desirable Qualifications:

• Experience in configuration management for medical devices or in a regulated industry

• Experience working under QMS.

• Familiar with Design Controls and with Document Control systems.

• Comfortable working with large databases and tools such as SAP and LCM tools such as Jama HPALM or Codebeamer

• Experience using a scripting or programming language.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.