Senior Design Assurance Engineer
Bachelor's degree in Mechanical Engineering or Electrical Engineering, or Computer Science or equivalent.
Experience in Design Assurance, ideally in a active medical device environment.
Proven ability to deliver proactive, pragmatic Design Assurance practices and deliverables within projects and services to drive practical yet compliant solutions using a mindset that strives for continuous improvement/simplification that retains Regulatory Compliance.
Proven ability to work collaboratively, balancing the needs of different and potentially conflicting view-points to deliver mutually agreeable solutions
Excellent organizational skills and a proven ability to plan and prioritize multiple workstreams/tasks.
Ability to communicate effectively at all levels, both written and oral.
Experienced in communicating to and negotiating with stakeholders at different levels of seniority and with different professional, cultural and ethnic backgrounds
Bioelectronic medicine is an emerging scientific field, aiming to use tiny implantable devices to change precise electrical signals in nerves to treat a range of debilitating chronic diseases. Galvani Bioelectronics represents an important step change in the research and development of these medicines, combining GSK's discovery and development expertise and deep understanding of disease biology with Verily's world leading expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications.
At Galvani Bioelectronics, we have demonstrated the feasibility of major inflammatory, metabolic, and respiratory diseases using neuromodulation of peripheral nerves in small animals. We have convincing reason to believe that these therapies, once proven through clinical studies, will bring a new therapy modality and help reduce the prevalence of major chronic diseases. Our ambition is to help patients, and through the development of efficacious therapies, become one of the world's largest neuromodulation companies.
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through total product lifecycle.
1.Adheres to Galvani's Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2.As a quality Core Team member actively participates in development project teams. Performs quality/reliability engineering activities while providing guidance to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
3.Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk / Benefit) and mitigations. Prepares required deliverables to execute and document the risk management outcomes, controls measures, residual risks in reports. Maintains risk management file for the life of the device.
4.Lead packaging and sterilization validation per EN/ISO 11607 and ISO 11135 respectively.
5.Coordinates with R&D in DAE review of technical documentation, develop test methods and prepare design verification and validation test deliverables. Plans and conducts compliance testing to recognized international standards.
6.Coordinates with Process Development in review of test fixtures/ test methodology, develop production acceptance criteria, test methods, and process validation protocols.
7.Provides support in supplier and internal auditing (DHF and Technical files for conformance), external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
8.Provides support in conducting root cause analyses, preparation of CAPA and HHA. Draft and update SOPs.
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