Manufacturing Engineering Manager

Salary: $110,000-$175,000We are NOT accepting resumes from recruitment agencies or search firms.About Instylla:Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups. The companys flagship product, Embrace Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.Position Summary:The Manufacturing Engineering Manager will be responsible for overseeing Instyllas manufacturing engineering efforts in the production of vascular embolic technologies and associated devices, ensuring product quality and scalability, driving continuous improvement initiatives, and supporting the companys long-term growth.Job Responsibilities:Develop and implement operational strategies that align with business objectives and that enhance product consistency, reliability, and scalabilityAct as a subject matter expert on manufacturing technologies, processes, and methodologiesSupport all aspects of the medical device manufacturing process, ensuring efficient production and compliance with quality standardsManage the development, validation, and optimization of manufacturing processes, including design transfer from R&D to manufacturingLead process transfers for both internal and external manufacturingUtilize data analytics to track performance, define metrics, and drive improvementsIdentify opportunities for process optimization and continuous improvement, reducing production costs while maintaining qualityManage partnerships with suppliers/vendors to maintain high-quality standards and timely deliveriesLead root cause analysis and corrective actions for production issues, product defects, customer complaints, and other technical challengesLead sustaining engineering initiatives including this related to supply chain and component obsolescence issuesManage engineering projects, budgets, and resources to achieve business objectivesProvide leadership, mentorship, and training to enhance team capabilitiesMaintain strict adherence to FDA, ISO 13485, and other regulatory requirementsFoster and maintain a culture of collaboration, innovation, and continuous learningQualifications & Requirements:Bachelors degree in manufacturing engineering, biomedical engineering, or other engineering disciplineMasters degree or other advanced degree preferredMinimum 7 years of manufacturing engineering experience in the medical device industry with a minimum of 2 years of supervisory experienceExperience in device manufacturing for peripheral vascular devices including implants preferredIn-depth knowledge of FDA regulations, ISO standards, and relevant industry guidelinesDeep expertise in various manufacturing methodologies including LEAN, Six Sigma, CAPA, SPC, and other problems solving methodsExperience with Minitab or other statistical evaluation softwareExperience scaling operations during periods of organizational growth, ideally in a start-up environmentAbility to recruit, retain and lead a highly competent teamProven track record in leading transformational change initiativesStrong understanding of regulatory impact on processes and alignment between functional operations and business strategyCAD experience (preferably SolidWorks)Experience with internal site and/or vendor transfersCollaborative with a track record of building cross-functional partnershipsAbility to use Microsoft Office applications proficientlyAbility to work well in a team and matrixed organizationExcellent communications skills, both written and oralStrong attention to detailAbility to solve problems independentlyCritical thinking and analysisWorking Conditions:Long periods of time working on a computerAbility to lift up to 25lbsOccasional travel (10-20%)A willingness to work in a laboratory environment is requiredA willingness to work in an Environmentally Controlled Area (ECA) is required

Salary : $96,400 - $131,900