Senior R&D Engineer
1 week ago
Description 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. 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. #J-18808-Ljbffr
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Senior R&D Engineer
1 week ago
Brooklyn Park, Minnesota, United States Biomerics Full timeSenior R&D EngineerBiomerics is seeking a highly skilled Senior R&D Engineer to play a key role in designing and developing guidewires from concept to production that meet and exceed customer expectations.Key Responsibilities:Lead Design and Development: Oversee the design, development, and validation of products throughout their life cycle, ensuring...
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Senior R&D Engineer
1 week ago
Brooklyn Park, Minnesota, United States Biomerics Full timeSenior R&D EngineerBiomerics is seeking a highly skilled Senior R&D Engineer to play a key role in designing and developing guidewires from concept to production that meet customer expectations.Key Responsibilities:Product Development Leadership: Lead design, development, and validation activities through the product life cycle for development products in...
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R&D Engineer
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R&D Engineer
3 months ago
Brooklyn Park, United States Nilfisk, Inc. Full timeMAJOR FUNCTIONThe R&D Design Engineer position contributes to both new product development and current product support reporting to the Technical Team Manager. You will apply principles and techniques of mechanical engineering and analysis in designing components, systems, & mechanical functions for floor maintenance products including autonomous...
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R&D Manager
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Menlo Park, United States Cambridge Recruiters Full timeI have an exciting cardiovascular startup in Menlo Park that’s looking for a Staff to Principal R&D Engineer to work on next-generation catheter-based devices for cardiovascular applications. Looking for a strong technical lead & mentor to junior engineers. New IP development.Technology: Steerable Catheter-based interventional devices for Cardiovascular...
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Manufacturing Quality Engineer
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Brooklyn Park, United States Cypress HCM Full timeA cutting-edge medical parts manufacturer in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will ideally come from Swiss Machining or Thermoplastics and will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and...
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Baldwin Park, California, United States Caelux Corporation Full timeAbout the RoleCaelux Corporation is seeking a highly skilled R&D Instrumentation and Lab Equipment Specialist to join our team in developing new Perovskite solar technologies that drive down the cost of green electricity.Key ResponsibilitiesSupport a diverse set of R&D lab fabrication and characterization equipment, including physical vapor deposition and...
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Menlo Park, United States Cambridge Recruiters Full timeSenior to Staff Manufacturing Engineer, Catheter Process DevelopmentWell-Funded 30-person Start-up Medical Device Company - Catheter Devices for Cardiovascular applications**MUST HAVE**: Catheter & Interventional Medical Device experience Title Flexible based on experience (Senior to Staff Engineer)Growth/Mentorship opportunity to train several younger...
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Baldwin Park, United States Ready Pac Produce, Inc Full timeJob DescriptionJob DescriptionPosition: Sr. Process Engineer Department: EngineeringReports To: Director, Technical Services (Engineering)Location: IrwindaleCompensation: The listed range for this position is $100-150K but the actual package offered may vary depending on different factors, including job-related knowledge, skills, and experience. The total...
