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Senior R&D Engineer

2 months ago

St Paul, United States Biomerics Full time

The Senior R&D Engineer will be responsible for designing and developing guidewires from concept to production that exceed customer expectations. JOB RESPONSIBILITIES : Ability to independently lead design, development, validation activities through product life cycle for development products in accordance to project scope. Leads execution of deliverables for Design Control process to deliver the desired product to production in a cost-effective manner while hitting product performance and?profitability goals. Complete and manage all Design History File(s), Design Controls, Design Verification & Validation, and all necessary activities in accordance to all internal and external processes, procedures and standards (MDR, ISO, EN, etc.) of varying project types. Ability to evolve the DHF to the project needs. Ability to lead, investigate and complete quality assurance deliverables (CAPA, NCMR, Deviation, RMA, SCAR (etc)). Ability to develop customer specification/requirements to translate into clear, concise performance and functional requirements with an upfront design for manufacturing mindset. Develop strategy for robust design, process, and testing criteria to satisfy requirements. Ability to independently create and lead engineering evaluation, characterization, design of experiments (DOE), bench testing or other verification activities to improve and confirm capability in the design and process. Be subject matter expert for all assigned product/projects Ability to assess, anticipate, and mitigate risks. Ability to optimally select risk assessment tools throughout the product development lifecycle. Lead and motivate development engineers/technicians/operators to perform hands on prototyping, testing, and process development [JW1] Ability to design advanced tooling/fixturing in a cost-effective manner. Discover, evaluate and implement new technologies and ideas for new products. Identify and use statistical tools to analyze data, make development decisions, and improve process capability (Six Sigma, SPC, DOE) Ability to independently develop, review and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated with emphasis on design for manufacturing. Provides engineering support and leadership to establish, implement and deliver products to production that meet project timeline, design, and profitability targets. Lead workflow and responsibilities with cross-functional teams and customers to establish, implement and deliver products to production that meet project timeline, design, and profitability targets. Ability to contribute to cross-functional continuous improvement activities. Requirements Preferred bachelor's degree in engineering with 6-10 years of medical device experience or a combination of work history in the medical device or relevant field totaling 9-12 years. In Depth Knowledge of design controls, process development, and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies. Efficient in 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications such as GD&T. Experience in a regulated environment and demonstrated competence in required documentation and industry accepted practices such as Good Manufacturing Practices (GMP), ISO 13485 Design Control, and Quality Systems Regulation (QSR). Complex problem-solving skills (e.g. use of statistical techniques such as design of experiments (DOE), Analysis of Variance (ANOVA), t-tests, normality, and process capability metrics in decision making). Excellent technical writing skills Strong internal and external communication, presentation, follow-through, and organizational skills. Proven ability to work effectively with coworkers at all levels of the organization. Demonstrated ability to lead team activities. Management, Coaching or mentoring experience a plus.