R&D Engineer III

Responsible for technical input into project level planning. Provide technical guidance to review work plans and advise on unusual features of projects Perform all duties in compliance with the quality management system; actively contribute to the continuous improvement projects. Responsible for technical input into project level planning. Provide technical guidance to review work plans and advise on unusual features of projects Provide technical, project level leadership to engineering assistants or junior engineering staff. Support cross functional team in Post Market Surveillance activities. Support the development of intellectual property where required. Support regulatory filings to various government bodies Mechanical/Biomedical Engineering degree required with a focus on biomedical experience 4+ years of related working experience from a regulated manufacturing industry 3+ years of relevant design control experience Experience with guidewire and catheter devices development. Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607 Experience with drafting and maintaining DHF and DMR documentations Experience with leading rapid design iteration and making design recommendations Ability to independently develops and adapts work plans based on vague or changing project goals Strong hypothesis-driven experimental design and statistical analysis skills Candidates should be self-starters and have a hands-on approach Ability to work independently and within a diverse group of Engineers and Production staff Strong communication skills (verbal/written) and demonstrated leadership skills Possess a strong interest in biomedical technology Self-starter with the ability to quickly learn about new processes Excellent analytical and communication skills (both written and oral) Able to work independently and in a multidisciplinary team environment