Sr Manufacturing Mechanical Engineer - Shockwave

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 89,000 - 142,600; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) pension and savings plan

Up to 120 hours of vacation annually

Job summary

Shockwave Medical Inc. is seeking a Senior Manufacturing Mechanical Engineer in Santa Clara, California. This role involves providing technical support for manufacturing lines, evaluating prototypes and tooling, and implementing changes to enhance product performance.

The ideal candidate will have a Bachelor's degree in Mechanical Engineering, along with 5 years of experience in process development for medical devices. Competitive benefits include a salary range from $89,000 to $142,600 and various medical insurance options.

Qualifications

• Minimum 5 years of experience in manufacturing development for commercial medical devices.
• Experience in regulated environments (ISO, FDA, cGMP).
• Ability to lift up to 25 lbs and travel abroad.

Responsibilities

• Support development transfer activities to contract manufacturers.
• Implement process improvement and cost-reduction projects.
• Analyze cost-reduction and efficiency opportunities.

Skills

Analytical skills

Problem-solving

Lean manufacturing

Communication skills

SolidWorks proficiency

Statistical proficiency

Education

Bachelor’s degree in Mechanical Engineering

Tools

Statistical analysis tools

Gantt charts

Smartsheet

Job description

Position Overview

The Senior Manufacturing Mechanical Engineer will provide technical support to contract manufacturers and component suppliers on the implementation and validation of manufacturing lines for Shockwave products. This includes evaluating and building prototypes, pilot and production equipment or tooling, troubleshooting, and implementing changes to improve manufacturing quality and product performance. The Senior Engineer will also identify and pursue value‑improvement and cost‑improvement projects to support operations in line with business goals.

Essential Job Functions

• Act as the primary technical point of contact with contract manufacturers and external partners to transfer and scale Shockwave manufacturing processes.
• Support development transfer activities from R&D & Operations to contract manufacturers/suppliers.
• Generate capacity/capability models and make‑vs‑buy assessments for local and international suppliers and manufacturing sites.
• Prepare and execute validation protocols, compile validation reports, and maintain process risk documentation (e.g., PFMEA).
• Prepare engineering change orders, coordinate implementation of changes, and provide training to production staff.
• Plan, schedule, and manage project timelines using project management tools.
• Implement process improvement and cost‑reduction projects, ensuring capacity matches the manufacturing plan.
• Apply lean manufacturing tools (factory layouts, visual management, 6S, JIT, Kanban) to improve material and information flow.
• Collaborate with cross‑functional teams during development phases to provide design for manufacturability (DFM) inputs.
• Develop and implement tools, fixtures, and equipment required for manufacturing processes, including support for 3D printing, UL impact testing, and material selection.
• Create manufacturing process instructions, inspection plans, and lot history travelers.
• Analyze cost‑reduction, quality, and efficiency opportunities, and lead design transfer of new products to production.
• Assist suppliers in product‑failure investigations to determine root causes and improve reliability.
• Ensure compliance with FDA, ISO, and company policies, and perform other duties as assigned.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• Minimum 5years of experience in all phases of process/manufacturing development, launch for high‑volume commercial or medical devices, and external product line transfer.
• Strong problem‑solving and analytical skills, including use of statistical analysis and design of experiments for product optimization and validation.
• Excellent organizational, verbal, and written communication skills with great attention to detail.
• Experience with lean manufacturing, design for manufacturability, and test implementation.
• Experience in balloon/stent catheter manufacturing and, preferably, braiding, coiling & laser processing operations.
• Proficiency with SolidWorks.
• Ability to interface with all levels and functions of the organization.
• Experience working in regulated environments (ISO, FDA, cGMP) and familiarity with Quality System requirements (e.g., traceability QSRs, ISO, MDD).
• Experience in program management and use of Gantt charts or Smartsheet.
• Statistical proficiency (Cpk, hypothesis testing, DOE, Gage R&R).
• Physical ability to lift up to 25lbs and travel abroad for implementation and qualification activities.

Compensation & Benefits

• Base salary range: $89,000 to $142,600 annually.
• Eligible for an annual performance bonus per company policy.
• Medical, dental, vision, life insurance, short‑ and long‑term disability, accident insurance, and group legal insurance.
• 401(k) pension and savings plan.
• Vacation up to 120hours per calendar year; sick leave up to 40hours; additional allowances for Washington residents.
• Holiday pay up to 13days per calendar year.
• Work, personal, and family time up to 40hours per calendar year.

EEO Statement

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.

Job posting is anticipated to close on March 11, 2025.