Sr Manufacturing Mechanical Engineer - Shockwave

Johnson & Johnson is hiring a Senior Manufacturing Engineer for Shockwave Medical located in Santa Clara, CA. Position Overview The Senior Manufacturing Mechanical Engineer will provide technical support to contract manufacturers and component suppliers for the implementation and validation of manufacturing lines for Shockwave products. Responsibilities include evaluating and building prototypes, pilot, and production equipment or tooling, troubleshooting issues, implementing changes to improve manufacturing quality and product performance, and supporting value‑and‑cost improvement projects aligned with business goals. Essential Job Functions Acts as the primary technical point of contact; works with contract manufacturers and external partners to transfer and scale Shockwave manufacturing processes. Supports development transfer activities from R&D and Operations to contract manufacturers and suppliers. Works with local and international suppliers and manufacturing sites to generate capacity/capability models and perform make‑vs‑buy assessments for site planning. Prepares and executes validation protocols and completes validation reports. Develops and maintains process risk documentation (e.g., PFMEA) and implements preventive and corrective actions. Prepares engineering change orders and coordinates implementation including training production staff. Provides project planning, timeline development, and schedule maintenance. Manages process improvement and cost‑reduction projects. Ensures capacity aligns with the manufacturing plan. Utilizes lean manufacturing tools (factory layouts, visual management, 6S, JIT, Kanban) to continuously improve material and information flow. Implements cost‑effective manufacturing processes to enhance product flow, quality, and safety for both existing and new products. Collaborates with cross‑functional teams during development and provides design‑for‑manufacturability input. Develops, tests, and implements tools, fixtures, and equipment required for manufacturing. Supports mechanical equipment improvements (e.g., 3D printing, UL impact testing, material selection). Creates manufacturing process instructions, inspection plans, and lot history travelers. Analyzes cost reduction, quality, and efficiency improvements. Leads design transfer of new products to production, establishing assembly time and yield targets, training needs, and quality controls. Assists suppliers with product failure investigations to determine root causes and implement effective containment and corrective measures. Complies with FDA, ISO, and company policies and procedures. Performs other duties as assigned. Qualifications Bachelor’s degree in Mechanical Engineering or related field. 5+ years of experience in all phases of process/manufacturing development for high‑volume commercial or medical devices and product line transfer. Strong problem‑solving and analytical skills; experience with statistical analysis and design of experiments for product optimization and validation. Excellent organizational, verbal, and written communication skills and attention to detail. Experience with lean manufacturing, design for manufacturability, and test implementation. Experience with balloon/stent catheter manufacturing. Experience with braiding, coiling, and laser processing operations is a plus. Proficiency with SolidWorks is a plus. Able to interface at all organizational levels; works cooperatively across functions. Experience in regulated manufacturing environments (ISO, FDA, cGMP). Knowledge of applicable quality system requirements (traceability QSRs, ISO, MDD) and other regulations. Experience in program management, use of Gantt charts or Smartsheet. Statistical proficiency (Cpk, hypothesis testing, DOE, Gage R&R) is a plus. Must be able to lift up to 25 lbs. Must be able to travel abroad to oversee implementation and qualification‑validation efforts. Additional Information Anticipated base pay range: $89,000 to $142,600 annually. The position is eligible for an annual performance bonus and other performance‑based compensation under company guidelines. Eligible benefit programs include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Eligible for the company’s retirement plan (pension) and 401(k) savings plan. Time‑off benefits: Vacation: up to 120 hours per calendar year. Sick time: up to 40 hours per calendar year (up to 56 hours for Washington state employees). Holiday pay (including floating holidays): up to 13 days per calendar year. Work, personal, and family time: up to 40 hours per calendar year. Additional information about benefits is available through the company website. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. NOTE: This job description is not intended to be all‑inclusive. Employees may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization. Johnson & Johnson is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 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