Principal R&D Engineer

Principal R&D Engineer Work on all elements of the Research & Development of novel minimally invasive devices, from concept generation through to commercialization.Implement cutting-edge technologies to provide the optimum design solution for products.Design concepts and prototypes in advance of selecting the most promising solution to take into Design Freeze.Develop plans and conduct testing for design verification and validation.Support the development of intellectual property within the company.Support Research and Development sustaining activities as they arise on commercial production lines.Required skills: Successful completion of a bachelor’s Engineering degree8+ years of related experience in engineeringExperience working in medical devices with focus on product developmentExperience with rapid design iteration and making design recommendationsExcellent SolidWorks skillsExcellent aptitude for mechanical engineering designStrong hypothesis-driven experimental design and statistical analysis skillsKnowledge of design requirements as per 21 CFR 820 and ISO 13485Experience with drafting and maintaining DHF and DMR documentationAbility to independently develop and adapt work plans based on vague or changing project goalsAbility to work independently and within a diverse team of engineers, professional staff, and production staffSuperior communication skills (verbal/written) and demonstrated leadership skillsStrong interest in biomedical technologyDynamic, flexible approach to work with a results-oriented attitudeCandidates must possess previous experience with the development of single use medical devices such as catheters, sheaths, guidewires, dilators, or balloon catheters.Experience with injection molding and hydrophilic coatingsAsset skills: Bachelor’s degree with a focus in Mechanical Engineering.Understanding of design for manufacture of medical devices.Experience with injection molding and hydrophilic coatings