The Release Coordinator role will be responsible for working with the Program/Product Management team to help coordinate our PoC rapid diagnostic Instrument and Connectivity Management Solution across the different areas, ensuring commercial success of product deliveries/releases by connecting the Product Management, Operations and Commercial teams.
The role involves working as part of the larger product team to ensure that product programmes and project releases are launched on schedule. The Release Coordinator will be responsible for helping to coordinate the deliverables from the R&D development programmes (program increments) with multiple cross-functional Agile teams and the wider organisational groups (such as Clinical, Operations, Customer Support, Supply Chain, Regulatory)
- Work with the System Lead and Product Owner to support the plan(s) for a number of projects as part of a SAFe Agile Release Train (ART)
- Work with the Program Manager and wider cross site team(s) to coordinate a plan of all phases and activities involved in the delivery that is outlined in our design and development and transfer to manufacturing processes
- Working with each ART Scrum team and support the System Lead to plan the following:
- Ensure all deliverables for a release are assigned and planned
- Track progress of each deliverable and ensure delays are caught as early as possible so corrective action can be taken
- Update the deliverable elements for a release ensuring standards compliance and QMS processes are followed
- Work with QA/RA to ensure document deliverables for a release are managed in alignment with the technical filing requirements
- Responsible for providing administrative and operational support to the Product Compliance (product registrations) department for Regulatory Affairs
- Help prepare and manage documentation for medical device registrations as directed
- Manage documents alongside ensuring they all have owners and are planned
- Working with the wider teams, look to improve the current document templates and documents contents
- Co-ordinate the review/approval/release cycle of documents in the document repository against plan
- Track progress of documents, identify delays and escalate corrective action
- Project Administration
- Acquiring the teams inventory requirements from internal and external sources
- Working with release teams to ensure deliverables can be shipped as required
Purpose of the role
The release coordinator shall work with the program manager to help with the release management cycle across the full product encompassing hardware, software, operations, QA/regulatory, clinical and clinical assay development.
The Release Coordinator will work as part of a Safe Agile Release Train across multiple Scrum teams and the wider organisation, with the responsibility for coordinating, planning and tracking required release assets.
Major aspect of the role will be to ensure that required assets (documentation, data, configurations) are delivered in line with the overall release plan.
Providing administrative and operational support to the product development teams and product compliance department for Regulatory Affairs. Helping prepare and manage documentation for medical device registrations as directed.
Key areas of responsibility
- Maintain documentation related to procedures on build and release, various notifications lists, and dependencies.
- Working as part of the larger product and project team to ensure that projects and releases are launched on schedule with maximum business value
- Develop and maintain release checklists for all releases, ensuring responsibility for completion/signed off of required documentation
- Maintain releases and associated documentation in line with specified standards and regulations, e.g. IEC 62304, ISO 13485 or FDA 21CFR, part 820
Communication and collaboration
- Communication with multiple stakeholders across the business, ensuring release goals are clear and impacts on release deliverables are communicated to relevant stakeholders
Act as an interface point between the R&D technical teams, operations, manufacturing, and QA/RA ensuring alignment between deliverables and technical file expectations relating to medical device registrations
What we are looking for
- Highly motivated individual that can demonstrate flexibility and a can do attitude.
- Ensures positive, productive and proactive relationships with a range of internal and external key stakeholders.
- Self-driven, takes ownership and demonstrates high levels of personal accountability, and is motivated to complete the goals and objectives
- Can listen and present effectively, providing progress updates and feedback on a regular basis
- Ability to plan and organise work in accordance with the overall objectives and required timelines
- Demonstrates the ability to solve problems under conditions of uncertainty and ambiguity and is able to think strategically in times of pressure to drive toward the best solutions
- Able to travel between company sites as needed
- High attention to detail is important
- Experience as a Project Coordinator in a complex high-tech projects that combines hardware and software through concept, feasibility, development, launch and post market
- Proven experience of working as a Project Coordinator in a regulated environment (preferably medical), helping managing and developing a release process
- Experience working across full product lifecycle in a regulated environment
- Experience working collaboratively with cross-site, remote distributed cross-functional teams
- Experience working with stakeholders to drive release deliverables to meet strategic goals
- Excellent written and verbal communication skills
- Background in medical device regulated industries
- Safe, Scrum and Agile experience would be beneficial but not essential
- Experience with release automation tools
- Experience in the use Jira and the program management tools for release planning and progress monitoring
- Experience with Document Repositories tools such as SharePoint
Degree qualified in computer science
Accepted degree subjects
- computer sciences
Additional job details
- Stirling · remote base considered
- £27,500 - £30,000
- Contract, dates and working times
How to apply
Please note, if you wish to submit an application for this role, please consider the following information
If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks we’ll conduct some pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
To register your interest in this role you will just need to submit your CV and some key information about yourself (no lengthy application form).
Click Apply to start your application now. This job will be available on Prospects until 31 May 2021
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Closing date: 31 May 2021