We are looking for a product owner (SaMD) to support the development and operational delivery of a medical device software application that plays a key role in one of our client's novel drug-digital combination products. The role offers the opportunity to sit at the heart of developing a new type of medical product that combines the best of drug and digital to make personalised medicine a reality in the mass market. This is a hybrid role so you will need to be able to get to their offices in Kings Cross around 10 days/ month.

You will have the opportunity to highly influence all stages of development and work alongside best of breed skillsets across Product, Technology, Regs and Clinical to develop your own skills and to grow as a uniquely experienced Product Leader in time.

You will work with all members of the multi-disciplinary product team (including product lead, tech leads, CRUX, developers and testers) and various stakeholders to help define the roadmap and then support the delivery in line with our strategic and quality objectives

You will work to establish (working hand in hand with the Product Design function) key deliverables along with feeding in user testing feedback and regulatory information to effectively document requirements inline with our QMS and broader Quality agenda.

This may be done via different artefacts such as flow diagrams, confluence pages and/or tables, ultimately feeding into tickets on Jira, all inline with established SOPs.

The aim is to clearly document product requirements, agree with all necessary persons, and then to build and test the product as per these specifications to the benefit of the end user.

As part of a small team your operational accountabilities will sit alongside the opportunity to contribute to our strategic agenda, and to take part fully in all facets of the product development lifecycle including origination, launch and scale-up.

You will have the opportunity to work across multiple markets and geographies and to build products that have a positive life changing impact for end users.

Responsibilities and Duties

• Helping to define a product that meets user needs and business goals
• Maintaining and prioritising the product backlog
• Preparing stories for the sprint backlog
• Working closely with the development team throughout delivery, providing the information they need to build the product
• Testing the product to ensure it does what it expected and meets requirements
• Tracking and reporting on progress
• Working with UX to design the product and learn from user testing
• Tracking usage of the product and iteratively improving it
• Ensuring that delivery meets regulatory requirements
• Working with doctors, patients and other stakeholders to develop a deep understanding of the problem and explore potential solutions
• Responsibility for key Quality Management activities and documentation working alongside the QA and Regs teams

Required Qualifications, Knowledge, Training and Experience

• Experience of delivering digital products, ideally mobile apps
• Experience of full product lifecycle, working closely with development teams
• Knowledge of agile
• Ideally experience of agile / scrum and user stories; working with distributed development teams
• Experience with Jira and confluence

Key Personal Characteristics

• Effective interpersonal skills and strong communication talent in order to establish sound relationships with colleagues, key partners and clients
• Methodical with the ability to follow procedures accurately
• Organisational skills with the ability to prioritise
• Ability to work under pressure and meet deadlines, showing attention to detail
• Flexibility, with an enthusiastic and confident approach; a willing member of the team
• Enjoys setting exemplary standards.
• A passion for healthcare and for going the extra mile required to create products that can meaningful impact quality of life for users

Desirable but not mandatory

• Medical experience or experience operating in a highly regulated industry.
• Familiarity with regulatory standards such as ISO 13485, ISO 14971, IEC 6236
• An understanding of regulated technology and life sciences products to facilitate smooth communication with both engineers and clinical teams.
• Experience working with Quality Management systems

Contact Henry Grover or Gail Kniveton 

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