Mfg Engrs Senior NPI Engineer

Position Title: Senior NPI EngineerReporting to: Maya Garcia (Sr. NPI Manager)1.1 COMPANY OVERVIEWMeraqi Medical now a part of Viant Medical provides design development and manufacturing services to medical device companies in the bioelectronics interventional and structural heart and minimally invasive surgical spaces. Meraqi provides solutions from early brainstorming conceptualizing and prototyping to full design and development as well as clinical and commercial Medicalis a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality life enhancing medical devices. We do this through our depth and breadth of capabilities end-to-end integration technical expertise and relentless focus on our customers and on operational excellence. With nearly 6000 associates across 24 locations worldwide we offer a unique combination of small-company service and attention with big-company resources. For more information follow us onLinkedIn.1.2 POSITION SUMMARYThe Senior NPI Engineer is responsible for leading the transition of new medical devices from product development into manufacturing while ensuring product quality regulatory compliance manufacturability and production readiness. This role serves as hands on technical lead for cross-functional product launches and collaborates with R&D Manufacturing Quality Regulatory Affairs Supply Chain and Operations to successfully introduce new products and process improvements and satisfy customer needs budgetary and schedule requirements.1.3 ESSENTIAL DUTIES AND RESPONSIBILITIESFollow Viant D&Ds policies and new product introductions from design transfer through commercial and execute manufacturing readiness plans for new product and implement robust cost-effective manufacturing processes and improve product flow and product quality and safety performance for both sustained and new manufacturing equipment development and assembly time and yield targets training needs and quality tooling equipment and fixture needs for the timely and cost-effective manufacture of medical and maintain manufacturing documentation including:Manufacturing InstructionsBills of Materials (BOM)RoutersDevice History Records (DHR)Device Master Records (DMR)Work InstructionsProcess Flow DiagramsDevelop and execute:MVP/IQ/OQ/PQ Process ValidationsEquipment QualificationsTest Method Validations (GR&R)Statistical analysis P-Value. Ppk Cpk transformation and resolve manufacturing issues during pilot and production root cause investigations using structured problem-solving methodologies (5 Why Fishbone DMAIC etc.).Lead Engineering Change Orders (ECOs) and implementation of design with customers and suppliers during product transfer and component Design for Manufacturability (DFM) and Design for Assembly (DFA) junior engineers and provide technical guidance during product Engineering Change Orders (ECOs) and implementation of design with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM).Work with R&D staff to ensure smooth transition of products into manufacturing while assuring manufacturability achieving cost targets and conformance with regulatory and quality analysis for cost reduction and quality and efficiency designs and processes when defects occur lead investigation to determine root cause and implement effective containment and counter with customers regarding process improvements process deviations and production KPI metrics prepare trending reports or project dashboard (product quality production rates downtime fulfillment etc.)Support in project planning and timeline development & management for design with customers suppliers and manufacturing staff to generate capacity/capability models and assessments used as an input to site and manage process improvement and cost reduction capacity is appropriate for the manufacturing detailed documentation throughout NPI transition to commercial manufacture and transfer to ultimate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled all work satisfies customer requirements and companys Quality Operations design input to Product Development other related responsibilities duties as assigned.1.4 REPORTING STRUCTUREReports to Sr NPI Manager.1.5 SUPERVISORY RESPONSIBILITYN/A1.6 REQUIRED EDUCATION EXPERIENCE SKILLS AND KNOWLEDGEBS in Industrial / Mechanical Engineering or equivalent engineering disciplineBachelors degree in engineering or equivalent experience; mechanical or manufacturing engineering preferred but not required.5 years of experience in medical device Quality Development Manufacturing and/or Program Management and/or Project Leadership on design transfers for neurovascular cardiovascular catheter-based bioelectronics or minimally invasive medical devices is of Lean Manufacturing and Six Sigma methodologies is transferring products between domestic and international manufacturing sites is with automation and manufacturing equipment development is ability to successfully bring products from concept to commercial with FDA QSR and ISO 13485 medical device to interact with client companies in a professional in contract manufacturing and/or manufacturing environmentExperience with lean manufacturing techniques value stream mapping and continuous improvement methodologiesSolid knowledge of GMP 21 CFR 820 and ISO 13485 regulationsStrong computer skills including the MS Office ERP and Doc Control systemsMust be able to read write and speak fluent English and must possess excellent communication skills both written and oralMust be able to prioritize and manage multiple deliverables while working in a fast-pace environmentProblem-solving skills and critical thinking; highly motivated focused self-starterQuality-driven customer serviceAble to work individually and as part of a of statistical techniques (DOE Gauge R&R SPC etc.)1.7 CORE COMPETENCIESCommunication SkillsAll verbal and written communications are concise technically accurate timely and strong verbal presentation and negotiation skills. Represents in a positive and professional ideas recommendations and solutions clearly logically and concisely in both written and verbal tact and diplomacy in active listening skills and ability to resolve discrepancies with customersManagement of Resources