Manufacturing Engineer II - Shockwave

The Manufacturing Engineer II is responsible for providing engineering support to Production, designing, developing, testing and implementing processes, tooling and fixtures for commercial product, and sustaining 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 the 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 (BOM’s) and Lot History Records (LHR’s) into Item Structures, Work Definitions and electronic LHR’s. 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. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel. Qualifications 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 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 Class 8 Cleanroom. Additional Information 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 the State of 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 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. Johnson & Johnson is an Affi­­­­vative 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. #J-18808-Ljbffr Dormont Manufacturing Co