Manufacturing Engineer II - Shockwave

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 73,000 - 117,300; Full time

Benefits offered by this job

Annual performance bonus

401(k) retirement plan

Medical, dental, vision insurance

Vacation and sick time

Holiday pay

Job summary

Shockwave Medical is hiring a Manufacturing Engineer II to provide engineering support to our production team in Santa Clara, CA. The role involves designing, developing, and implementing manufacturing processes, tooling, and fixtures for our products.

Qualified candidates will have a Bachelor’s degree in engineering and 3-5 years of experience in the medical device field. Compensation includes a base pay of $73,000 – $117,300 per year and a comprehensive benefits package.

Qualifications

• 3-5 years of experience in a medical-device environment.
• Ability to create and maintain drawings in SolidWorks.
• Basic understanding of statistics (Cpk, hypothesis testing, DOE, Gage R&R) is a plus.

Responsibilities

• Provide engineering support to Production.
• Design, develop, test, and implement processes, tooling, and fixtures.
• Document results and provide statistical analysis.

Skills

Quality System requirements compliance

Lean and Six Sigma understanding

Medical Device Validation (IQ-OQ-PQ)

SolidWorks

MES and ERP (Oracle)

Education

Bachelor’s degree in engineering

Tools

Minitab

Excel

Job description

We are hiring a Manufacturing Engineer II – Shockwave Medical to join our team located in Santa Clara, CA.

Position Overview

The Manufacturing Engineer II is responsible for providing engineering support to Production and for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial products. The role also sustains activities on the production line such as raw material, process and equipment issues.

Essential Job Functions

• Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
• Actively identify and participate in process/product, tooling, equipment, fixtures, and cost‑reduction improvement projects.
• Coordinate and/or perform functional and destructive testing to support Engineering Reports.
• Document results and provide a statistical analysis using Minitab or Excel.
• Participate as an extended team member for new product introduction, including scaling up, stabilizing, and transfer to alternate sites.
• Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
• Create, maintain, and transfer paper Bill of Materials (BOMs) and Lot History Records (LHRs) into Item Structures, Work Definitions, and electronic LHRs.
• Support efforts to resolve quality‑related events (NCR, CAPA, Audit Finding) and maintain other Quality System requirements.
• Create and release label files used for printing product labels.
• Create and execute process validation protocols and reports.
• Other duties as assigned.

Qualifications

Bachelor’s degree in engineering and 3‑5 years of experience in a medical‑device environment.

• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ‑OQ‑PQ).
• Basic understanding of statistics (Cpk, hypothesis testing, DOE, Gage R&R) is a plus.
• Ability to create and maintain drawings in SolidWorks.
• Ability to work in a fast‑paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Experience with MES and ERP (Oracle) preferred.
• Employee may be required to lift objects up to 25lbs or more.
• Employee will be required to work in an air‑conditioned Class8 Cleanroom.

Compensation and Benefits

• Base pay: $73,000 – $117,300 per year.
• Eligible for an annual performance bonus.
• Medical, dental, vision, life insurance, short- and long‑term disability, business accident insurance, and group legal insurance.
• 401(k) retirement plan and savings match.
• Vacation up to 120hrs per calendar year; sick time up to 40hrs per calendar year (up to 56hrs for employees in Washington).
• Holiday pay, including floating holidays, up to 13days per calendar year.
• Work, personal and family time up to 40hrs 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.

This job posting is anticipated to close on March11,2025.