Medical Device Senior Manufacturing Engineer
hace 1 mes
The Senior Manufacturing Engineer will play a critical role in fostering collaboration between R&D, Pilot, and commercial manufacturing phases to contribute from Early Human Use to the commercialization of new medical products. This position will ensure that design and manufacturing processes are characterized, robust, scalable, and compliant with regulatory requirements while utilizing the best technologies and methodologies such as LEAN Six Sigma and Design for Manufacturing.Compensation and BenefitsCompetitive salary based on experienceHealth, dental, and vision insuranceRetirement savings plan with company matchingGenerous vacation and paid time off policyFlexible working hoursOpportunities for professional development and continuous learningRemote work options availableWhy you should apply for this position todayThis is an outstanding opportunity to join a dynamic team dedicated to improving medical device manufacturing processes. You will have the chance to work on innovative projects that significantly impact patient care while collaborating with esteemed professionals in the field.SkillsStrong knowledge of cart systems, console operations, and electromechanical devicesProficient in SolidWorks for modeling and drawingExperience with contract manufacturers and capital equipmentTechnical expertise in DFM, Six Sigma, LEAN, cGMP, and process validationAbility to conduct pFMEA and develop process validationsHighly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMPLean and / or Six Sigma certifications are a plusResponsibilitiesDevelop and optimize manufacturing processes for medical devicesProduce production-level assembly and part drawingsIncorporate DFM, Six Sigma, and LEAN principles into designsIdentify and evaluate contract manufacturing partnersLiaise between Contract Manufacturing Organization (CMO) and CanonReview engineering specifications and CAD dataManage part / drawing release and BOM accuracyExecute experiments and tests on product linesConduct Characterization and Validation activitiesCreate and maintain manufacturing documentationCoordinate technical communicationsQualificationsBachelors degree or higher in Mechanical Engineering5+ years of experience in medical device manufacturing engineeringAt least three years in new product development and production design transferProven track record in design transfer and process validationExperience in troubleshooting and optimizing electromechanical systemsStrong modeling skills in SolidWorksEducation RequirementsBachelors degree in Mechanical Engineering or a related fieldExperience RequirementsMinimum of 5 years in medical device manufacturingExperience in managing and improving cart / console systemsFamiliarity with sterilizable polymers and catheter fabrication techniquesWhy work in Cambridge, MACambridge is a hub of innovation and collaboration, home to many leading universities and research institutions. The vibrant atmosphere fosters creativity and growth, with a strong focus on technology and health care. The city offers a rich cultural experience, diverse dining options, and ample opportunities for professional networking and advancement, making it an ideal place for your career development.Employment Type : Full-TimeEducation Level : Bachelor's degreeRequired Knowledge, Skills, and Abilities :Do you have a bachelors degree or higher in Mechanical engineering?Do you have 5+ years of experience in medical device manufacturing engineering, including at least three years in new product development, design transfer to production, and validating processes?Do you have experience working with cart systems, console operations, and electromechanical devices, including hands-on experience in troubleshooting, maintaining, and optimizing these systems in a mechanical and electrical integration environment?Do you have excellent modeling and drawing skills using SolidWorks, including proficiency with assemblies that contain dozens of parts?Do you have experience working with contract manufacturers / vendors for capital equipment, electronics testing, and/or catheter manufacturing?Do you have a proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques?Do you have technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation?Are you proficient in SolidWorks with experience in tool and fixture design?Are you highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP for process monitoring and improvement?Do you have Lean and/or Six Sigma certifications?Must be a US Citizen or Green Card holder.
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