Staff Manufacturing Engineer - Shockwave

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 105,000 - 169,050; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) savings plan

Up to 120 hours of vacation annually

Performance bonus

Job summary

Shockwave Medical Inc. is seeking a Staff Manufacturing Engineer in Santa Clara, California. The role involves designing, developing, testing, and implementing manufacturing processes for intravascular lithotripsy devices.

The ideal candidate will have at least 8 years of experience in a medical device environment, a Bachelor’s degree in Mechanical or Biomedical Engineering, and proficiency in tools like SolidWorks and Minitab. Compensation ranges from $105,000 to $169,050 annually with various benefits.

Qualifications

• At least 8 years of experience in a medical device environment.
• Proficient in written and verbal communication, including presentations.
• Knowledge of Quality System requirements like QSRs and FDA.

Responsibilities

• Design and implement manufacturing processes for IVL device.
• Collaborate with R&D, QA, and Production.
• Analyze process performance data for products.

Skills

Process Validations

Lean Manufacturing

Statistical analysis

SolidWorks

Minitab

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Job description

Position Overview

The Staff Manufacturing Engineer will design, develop, test, document, and implement processes, tooling, and fixtures throughout the product lifecycle, from concept to production, in support of Shockwave Medical’s intravascular lithotripsy (IVL) device development and commercialization.

Essential Job Functions

• Collaborate with R&D, QA, and Production to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
• Collect and analyze process performance data for new and existing products.
• Perform tolerance analysis for components, materials, packaging, and supplies.
• Lead development and maintenance of process Failure Modes and Effects Analyses (pFMEAs).
• Prepare user requirements, technical specifications, and design specifications.
• Identify process requirements, advise operations management, and implement equipment and fixtures for process development.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, and other Quality System requirements.
• Evaluate existing engineering processes and implement improvements.
• Lead or actively participate in process/product engineering problem‑solving using DMAIC methodology.
• Assist Procurement and R&D with supplier selection and technical development.
• Recommend new technologies to improve system performance and reliability.
• Perform productivity and costing analyses, including direct labor, time studies, and material cost calculations.
• Identify opportunities and implement cost‑reduction plans for existing products.
• Support product line transfer and qualification‑validation efforts.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Minimum eight (8) years of experience in a medical device environment, or six (6) years with a Master’s degree.
• Knowledge of applicable Quality System requirements such as QSRs, FDA, ISO, MDD, and related regulations.
• Experience with Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing, statistical analysis, capability studies (Cpk), DOE planning and analysis.
• Proficiency in written and verbal communication, including presentation delivery.
• Ability to use specialized software such as SolidWorks, Minitab, or similar.
• Ability to work in a fast‑paced environment, managing multiple priorities independently or in a team.
• Occasional lifting of objects up to 25 lbs is required.

Compensation and Benefits

Base pay range: $105,000 to $169,050 annually. Eligible for an annual performance bonus per company guidelines.

• Medical, dental, vision, life insurance, short‑term and long‑term disability, business accident insurance, and group legal insurance.
• Consolidated retirement plan (pension) and savings plan (401(k)).
• 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.

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 veteran status, and will not be discriminated against on the basis of disability.