Role: Head of Product at Vital Signs Solutions
Location: Cambridge, UK
Salary: Competitive compensation package
Reports to: CEO
Job summary:
We are a high-growth digital in-vitro diagnostic start-up looking for a Head of Product to join our expanding team. You will be responsible for transitioning products from R&D to production to launch and will manage the laboratory operations at our QMS-13485 regulated lab in Cambridge. You will be a member of the executive management team working closely with the CEO to plan manufacturing strategy, operations and drive company growth. You enjoy working in a fast-paced dynamic environment and have a passion for digital technologies.
Key Responsibilities
Manage the laboratory operations
Manage a team of production scientists
Provide scientific insight, direct research to solve scientific problems
Responsible for the technology transfer of production from R&D to production
Responsible for supply chains and manufacturing
Responsible for the completion of raw material specifications, in-process and out-sourced QC documentation and verification / validation processes in partnership with QA/RA director
Ensure compliance of laboratory with QMS-13485
Own the company’s manufacturing strategy and plan
Responsible for scaling prototypes to higher launch volumes
P&L responsibility for manufacturing function
Monitor the industry landscape with a particular focus on incremental innovations applicable to our products
Responsible for the life-cycle management of existing product
Qualifications & Experience Required
Minimum 10 years experience working in manufacturing within diagnostic or medical device companies
Minimum 5 years management experience, ideally managing a commercial laboratory
Proficiency in quality systems (ISO 13485), associated documentation and processes
Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR)
Experience in tech transfer from R&D setting
Experience in establishing and managing supply chains
Experience in lateral flow device manufacturing a plus
Experience of software as a medical device (SAMD) a plus
Background in chemistry, particularly surface chemistry, a plus
Strong communication skills
Passionate about technology, healthcare and entrepreneurship
Experienced in working in cross-functional teams
Driven, motivated and organised
Working independently with a high level of accountability
Application process
To apply, please send (by e-mail) a cover letter demonstrating your suitability for this position, a detailed CV to info@vitalsignssolutions.com