Product Development Manager
Cambridge- Biotech- Hybrid Working- Medical Devices- Software
This is a great opportunity for a Software Development Manager to join a leading biotechnology company in Cambridge. They are a dynamic and innovative company focused on the development of new ground-breaking technologies in liquid biopsies.
The Software Product Development Manager is responsible for managing all aspects of the delivery of new and improved products within the company’s product portfolio from project initiation to product launch. You will be managing a cross functional team and stakeholders ensuring retention of focus on quality compliant delivery.
- New Product Selection – support the review of new product ideas and, working as part of a cross-functional team, develop a robust business case to support product selection.
- Design Planning – work with relevant stakeholders to identify and document customer/user requirements and develop design plans, including Software Development Plans.
- Design Inputs – oversee completion of software requirement documentation, ensuring alignment with the user and product requirements.
- Design and Development (incorporating verification, validation and design transfer) – oversee and be accountable for progressing the product development under stage gated design control procedures including software verification and validation. Input into, and review software documentation (Level of Concern, software requirements, architecture, software design specifications) as required. Lead, manage and document design review meetings. Ensure completeness of design history file or technical file documentation suitable for regulatory compliance. Contribution to Companion Diagnostic projects as and when required.
- Monitoring and Control – implement formal project management techniques and reporting relating to timelines, risk, quality, scope change. Chair and minute regular cross-functional product development project meetings and record key actions and decisions. Prepare regular presentations and report updates on progress to the executive team.
- Closure – ensure completion of all documentation, facilitation of lessons learned, ensure post-market controls are in place and assist with ensuring development benefits realisation occurs.
- Ensure the product software changes are managed in accordance with approved change management procedures. Work cross-functionally to assess the impact of proposed design changes that may impact the product software and ensure continued compliance with relevant regulatory requirements.
- Ensure that the project is developed to be compliant with the associated product regulatory pathway and work closely with the Quality and Regulatory Teams to ensure regulatory completeness and compliance.
Risk and Issue management:
- Document, assess, categorise, and monitor risks and issues relating to the project from both the product and business perspective. Lead the development of Software Hazard Analysis and FMEA, and work with the wider product development teams to ensure successful verification and validation of identified risk control measures. Ensure all key product development project decisions are logged.
- Degree in Computer Science or Software Engineering discipline
- Project Management certification preferred
- Experience developing medical device software
- Demonstrated experience managing the delivery of Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) in a fast paced, changing global IVD environment
- Experience of successfully managing multiple product development software projects simultaneously to high quality standards.
- Experience of developing and implementing Product Development and Design Control processes to support the delivery of SaMD / SiMD in accordance with ISO 62304.
If you are interested in finding out more about this role, please send your CV to Sabrina Deo at email@example.com