Manufacturing Engineer II - Shockwave

Manufacturing Engineer II - Shockwave Medical located in Santa Clara, CA
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The Manufacturing Engineer II is responsible for providing engineering support to Production, designing and implementing processes, tooling, and fixtures for commercial product, and sustaining activities on the production line.

• Actively collaborate with Production to provide sustaining support in resolving product, process, or equipment problems.
• 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, documenting results and providing 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 findings) 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. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

• Bachelor’s degree in engineering.
• 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’s, Gage R&R) – a plus.
• Able to create and maintain drawings in Solid Works.
• 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 25 lbs or more.
• Employee will be required to work in an air‑conditioned Class 8 Cleanroom.

• The anticipated base pay for this position is $73,000.00 to $117,300 annually.
• The Company maintains highly competitive, performance‑based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time‑off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time – up to 40 hours per calendar year; for employees who reside in Washington – up to 56 hours per calendar year
  • 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 can be found through the link below.

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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