Principal Manufacturing Engineer

Senior Manufacturing EngineerA well-established medical device manufacturer is seeking a Senior Manufacturing Engineer to join their team. This is a senior leadership role within a hands-on manufacturing and engineering environment, including ISO Class 7 cleanroom operations. Occasional travel to additional facilities in Gardner, MA and Portland, ME is required.This role leads design transfer out of R&D and is responsible for developing, implementing, and continuously improving manufacturing capabilities across new and existing product lines. The Senior Manufacturing Engineer serves as a best-practice leader within the product development organization, ensuring that products are optimally designed for manufacturability while driving improvements in productivity, product quality, and cost efficiency.Manufacturing Process DevelopmentLead design transfer activities from R&D into full-scale manufacturingDesign and develop manufacturing processes, tooling, and fixtures for new products, product changes, and enhancements — targeting zero-defect outcomes and competitive cost structuresProvide DFM guidance to product development teams covering mechanical assembly, dimensional tolerancing, electrical wiring, materials selection, and fabrication methodsPerform IQ, OQ, PQ, and Design of Experiments (DOE) activitiesEstablish best practices and author manufacturing procedures; develop and maintain Bills of MaterialsSupport prototype and pilot production in coordination with R&D, Manufacturing, and Quality ControlOperations & EquipmentEvaluate capital equipment, generate appropriation justifications, and support procurement decisionsOversee preventive maintenance programs for equipment and toolingManage production of consumables and hardware including scheduling, building, testing, packaging, labeling, sterilization coordination, and distribution handoffsCoordinate work with outside vendors, technicians, and tool room personnelProvide engineering support to production in troubleshooting and resolving technical issuesDocumentation & ComplianceCreate and maintain accurate documentation of design concepts, tool drawings, and shop orders in coordination with Quality Assurance and R&DMaintain factory GMP compliance in coordination with Document Control, R&D, and Quality AssuranceEnsure adherence to all applicable regulatory requirements and internal policies including FDA regulations and Good Manufacturing PracticesTeam LeadershipLead a small team of Manufacturing EngineersTrain technicians and manufacturing personnel on equipment operation, procedures, and inspection methodsProvide guidance and mentorship to junior engineering personnelPlan and schedule projects in alignment with corporate objectivesRequired:Bachelor's or Master's degree in Engineering or a related discipline10–15 years of related manufacturing engineering experienceDemonstrated experience with complex electro-mechanical and/or opto-mechanical products and manufacturing processes; low-to-medium volume production environment preferredExperience with Design of Experiments and statistical analysis toolsProficiency in Microsoft Word, Excel, Project, and PowerPointAbility to work on complex problems requiring in-depth evaluation of multiple variables and exercise of independent judgmentUS citizenship or US person status requiredPreferred:Experience with disposable or single-use medical devicesSix Sigma Black Belt certificationFull-time, onsite position — Monday through FridayWork performed in manufacturing, engineering laboratory, and ISO Class 7 cleanroom environments; PPE required in controlled areasOccasional travel of 10–15%, including visits to facilities in Gardner, MA and Portland, MEStandard use of office equipment; hands-on use of mechanical and electrical manufacturing tools and equipmentThis employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law.