Senior Design Engineer -IVD medical devices
My client offers an affordable, real-time PCR system that can serve as the basis for rapid detection, quantification, or drug resistance testing of infectious diseases and pathogens, such as TB or Hepatitis.
As they further develop their Point of Care philosophy through product development and refinement, they have an opportunity to reach millions of people who currently have limited access to existing diagnostic technology.
Ultimately, their goal is to change lives through rapid access to the benefits of molecular diagnostics.
Due to a ramp up of their focus on delivering affordable point of care in vitro molecular diagnostics for addressing global infectious disease challenges, my client are looking to strengthen their product engineering team with the addition of an experienced industrial design engineer to support the HCV and TB IVD consumable plastic/ fluidic device programmes; enhancing their system for future success and global impact.
• Mechanical/industrial design, prototyping, design verification and manufacturing transfer and component verification
• Acting as the industrial design subject matter expert, working closely with programme managers and outsource industrial design innovation companies, contributing to concept development, design transfer oversight, part verification and whole system validation
• Leading design history creation including origination of 3D assembly models, schematics, BOMs, material specifications and verification protocols within an ISO 13485 product design and manufacturing environment
• Working closely with cross-functional teams of R&D scientists, electronic and software engineers in product design specification, human factors, user experience and FMEA
• Supporting internal Operations and outsourced manufacturing teams in process development, validation and incoming goods QC/ component checking
• Support Quality/Regulatory teams with CAPA, out-of-spec/non-confirming product investigations on company mechanical/ consumable parts
• Maintain good, clear communication with Managers and Directors.
Salary is negotiable on experience
Are you prepared to begin a new chapter in your career? If so, this could be the role for you! For more information and a confidential discussion, please contact Kieran Whittaker on: -
Tel: - 0161 923 8174
Email: - Kieran.firstname.lastname@example.org