Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes - What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market vigilance.
Requirements: Bachelor's Degree in an engineering or equivalent
At least 4-6 years of experience in quality engineering in the medical device industry- Must
Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971, IEC 62366 and ISO 62304 standards for the medical devices industry
DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
Good ability to comprehend multi-disciplinary systems and processes
Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
Ability to work independently with minimal supervision
Computer skills (Microsoft Word, Excel, PowerPoint)
Working knowledge in Statistical Tools, e.g. miniTab (Measurement Systems Analysis, Process Capability and Statistical Process Control)
Knowledge of various quality system methodologies Lean, 5 Whys, DFMEA, PFEMA, PPAP, etc. preferred
Strong written and verbal communication skills
Strong organizational skills
Excellent written and spoken English
This position is open to all candidates.