Sr. NPI Engineer - Johnson and Johnson MedTech, Circulatory Restoration

Position Overview

The Senior NPI Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design through production. This role will work closely with Production, Quality, and R&D teams to support the manufacturing operations and ensure timely product launches.

Essential Job Functions

• Collaborate with R&D, Quality, Regulatory, and Production teams to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
• Support Quality in addressing and resolving non-conformances.
• Collect and analyze process performance data and capabilities for both new and existing products.
• Identify process requirements and support operations by designing, developing, and implementing equipment and fixtures for process development and manufacturing.
• Develop and maintain documentation in compliance with design control, product configuration, manufacturing procedures, and lot history records (e.g., Bills of Materials, MPIs, LHRs), in alignment with FDA, ISO, MDR, and other applicable Quality System requirements.
• Prototype and develop designs, processes, and test methods to support new product development and scale-up for commercialization.
• Create and execute process verification and validation protocols and reports.
• Represent Operations as the primary point of contact for manufacturing-related project activities, including responding to internal and external requests and supporting pilot manufacturing.
• Stay current with competitive technologies and advancements in medical, technical, and biomedical fields related to the company's products.
• Lead or participate in product and process engineering problem-solving using DMAIC or similar methodologies.
• Drive or support continuous improvement projects for processes and products, working closely with development engineers and technicians.
• Apply Lean manufacturing principles to reduce waste and improve productivity in production processes.
• Support Procurement and R&D with supplier selection and process development.
• Conduct productivity and cost analyses, including calculating direct labor and material costs for new and existing products, and identifying cost reduction opportunities.

Requirements

• Bachelor's degree in Mechanical or Biomedical Engineering with 5+ years' of engineering experience, or a Master's degree in Mechanical or Biomedical Engineering with 3 years' of engineering experience (preferred).
• Engineering experience in the medical device industry is highly preferred.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other relevant regulations.
• Understanding of Lean and Six Sigma principles.
• Experience with medical device validation (IQ-OQ-PQ).
• Basic understanding of statistical methods (e.g., Cpk, Hypothesis Testing, DOE's, Gage R&R) a plus.
• Proficiency in SolidWorks for creating and maintaining drawings.
• Experience with ERP and MES (Oracle preferred).
• Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
• Experience in early-stage catheter based cardiovascular devices project is a strong plus.
• Effective communication skills across all levels of the organization.
• Proficiency in Microsoft Office software (Excel, Word, PowerPoint).
• Ability to work in a fast-paced environment while managing multiple priorities.
• Ability to work both independently and collaboratively, with flexibility to adapt to changing requirements.
• Must be able to sit for prolonged periods (more than 2 consecutive hours in an 8-hour day).
• Must be able to lift objects weighing up to 25lbs or more.