Cambridge Recruiters
Senior Research And Development Engineer
Cambridge Recruiters, Pleasanton, California, United States, 94566
Overview
This Senior Research And Development Engineer role is for a Commercial-Stage, 200-person minimally-invasive interventional technology medical device company. The company is well-funded with $50MM in financing recently secured. You will work as part of a highly collaborative, multidisciplinary team and interface with Manufacturing, Quality, Marketing, Clinical, and Regulatory teams to integrate and implement design solutions for commercialized products. Base pay range and additional compensation are provided below. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Compensation
Base pay range : $135,000.00/yr - $165,000.00/yr Additional compensation types : Annual Bonus and Stock options Responsibilities
Lead and inform the design, development and qualification strategy for design-related product enhancements and line extensions in response to internal and/or external feedback. Lead design-related root cause analysis efforts, and drive corrective and preventive actions. Serve as an R&D subject-matter expert for projects led by cross-functional teams, and partner to gain alignment on qualification strategies. Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development. Collaborate with the Post-Market Surveillance team to support effective root cause analysis of device issues returning from the field. Ensure design and development pathways maintain adherence to the design control process, enabling manufacturability, reliability, and scalability with cross-functional partners. Use SolidWorks to create well-defined models, assemblies, and engineering drawings. Support the generation of new or revised product requirements and engineering specifications. Create and execute protocols, and author associated reports and risk documentation, developing and validating new test methods as needed. Effectively communicate project progress, results, and risks to relevant stakeholders. Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed, ensuring alignment with project goals and timelines. Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field 5+ years of MEDICAL DEVICE experience
(4+ with an advanced degree) Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820 Ability to apply DFX principles to create designs that can scale Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T Track record of taking design concepts from prototyping stage through to design maturation Proven design capabilities in two or more of the following areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics Experience creating and running simulations (CFD, FEA) to inform product development Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams Strong problem-solving and analytical skills, with a hands-on approach to product development and testing Must Have US Work Authorization or be a US Citizen (No Sponsorships or C2C candidates) Local Candidates preferred; however, some assistance may be offered for well-qualified candidates from out of the area. Employment details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Design Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cambridge Recruiters by 2x
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This Senior Research And Development Engineer role is for a Commercial-Stage, 200-person minimally-invasive interventional technology medical device company. The company is well-funded with $50MM in financing recently secured. You will work as part of a highly collaborative, multidisciplinary team and interface with Manufacturing, Quality, Marketing, Clinical, and Regulatory teams to integrate and implement design solutions for commercialized products. Base pay range and additional compensation are provided below. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Compensation
Base pay range : $135,000.00/yr - $165,000.00/yr Additional compensation types : Annual Bonus and Stock options Responsibilities
Lead and inform the design, development and qualification strategy for design-related product enhancements and line extensions in response to internal and/or external feedback. Lead design-related root cause analysis efforts, and drive corrective and preventive actions. Serve as an R&D subject-matter expert for projects led by cross-functional teams, and partner to gain alignment on qualification strategies. Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development. Collaborate with the Post-Market Surveillance team to support effective root cause analysis of device issues returning from the field. Ensure design and development pathways maintain adherence to the design control process, enabling manufacturability, reliability, and scalability with cross-functional partners. Use SolidWorks to create well-defined models, assemblies, and engineering drawings. Support the generation of new or revised product requirements and engineering specifications. Create and execute protocols, and author associated reports and risk documentation, developing and validating new test methods as needed. Effectively communicate project progress, results, and risks to relevant stakeholders. Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed, ensuring alignment with project goals and timelines. Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field 5+ years of MEDICAL DEVICE experience
(4+ with an advanced degree) Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820 Ability to apply DFX principles to create designs that can scale Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T Track record of taking design concepts from prototyping stage through to design maturation Proven design capabilities in two or more of the following areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics Experience creating and running simulations (CFD, FEA) to inform product development Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams Strong problem-solving and analytical skills, with a hands-on approach to product development and testing Must Have US Work Authorization or be a US Citizen (No Sponsorships or C2C candidates) Local Candidates preferred; however, some assistance may be offered for well-qualified candidates from out of the area. Employment details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Design Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cambridge Recruiters by 2x
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