Staff Manufacturing Engineer Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is hiring for aStaff Manufacturing Engineer - Shockwave Medicalto join our team located inSanta Clara CA.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Staff Manufacturing Engineer is responsible for designing developing testing validating and implementing processes tooling and fixtures for on-market products. The Staff Manufacturing Engineer will work closely with integration teams and serve as a core member of the team through successful implementation into the companys manufacturing operations.

Essential Job Functions

• Work collaboratively with R&D QA and Production departments to design develop test document and implement processes tooling and fixtures.

• Collect data and analyze process performance and capabilities for company products including new products and products already in production.

• Perform tolerance analysis for components manufacturing materials packaging and supplies used for in-house processing.

• Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company processes.

• Lead and/or actively participate in efforts to integrate new systems into the production environment. Prepare user requirements functional requirements participate in validations transfer of data from legacy systems and end user training.

• Identify process requirements advise and support operations management and implement equipment and fixturing needed for process improvement and manufacturing efforts.

• Develop and maintain documentation for design control product configurations manufacturing procedures lot history records (-of-materials MPIs LHRs) and other Quality System requirements.

• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.

• Lead and/or actively participates in process/product improvement projects (in cooperation with production R&D engineers and technicians).

• Recommend new technologies to improve system performance and reliability. Performs productivity and costing analyses (e.g. calculate direct labor time studies& materials costs for new and existing products)providing solutions that improve efficiency and scalability for years to come.

• Identify opportunities and implement cost reduction plans for existing products.

• Support the transfer of product lines and the qualification-validation efforts.

• 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.

Requirements

• Bachelors degree in Mechanical/Biomedical Engineering or equivalent experience

• Minimum of eight (8) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations or 5 years of experience with a Masters Degree.

• Knowledge of and compliance with applicable Quality System requirements such as QSRs FDA ISO MDR and other applicable regulations.

• Experience and understanding Process Validations (IQ OQ PQ) 6S Lean Manufacturing

• Experience applying statistics and using statistical software running Capability Studies (Cpks) and planning and analyzing DOEs.

• Experience with MES ERP and/or PLM systems

• Demonstrated proficiency in written and verbal communication including creating and delivering presentations.

• Ability to use special software such as: Solidworks Minitab or closely related.

• 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.

• Employee may be required to occasionally lift objects up to 25 lbs.

Additional Information

• The anticipated base pay range for this position is $109000 to $174800 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys 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

• Additional information can be found through the link below. 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 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

  Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

  Required Skills:

  Preferred Skills:

  Accelerating Coaching Critical Thinking Facility Management Good Manufacturing Practices (GMP) Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Engineering Performance Measurement Product Design Program Management Project Engineering Project Schedule Risk Compliance Robotic Automation Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy

  The anticipated base pay range for this position is :

  $109000.00 - $174800.00

  Additional Description for Pay Transparency: