Johnson & Johnson is recruiting for Principal Manufacturing Engineer for Shockwave Medical Inc. located in New Brighton, MN.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

• Work collaboratively with R&D, Quality and Production departments to design, develop, test, validate 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 analyses for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Participate in development and maintenance of product design FMEAs.
• Identify requirements, advise Operations management, prepare proposals and implement equipment & fixturing needed for development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations (e.g., bills-of-materials), and other Quality System requirements.
• Lead and/or actively participate in product/process engineering problem resolution.
• Lead and/or actively participate in process/product improvement projects, Validation activities (IQ, OQ and PQ) in cooperation with R&D engineers, Quality and technicians
• Assist Materials, QA and R&D departments with supplier selection and technical development
• Conduct complex engineering studies and investigations and prepare reports for company leadership
• Provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.
• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).
• 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 discipline (Mechanical, Biomedical, etc.)
• Minimum of ten (10) years of experience in medical device manufacturing with BS or, eight (8) years of experience with MS or PhD degree.
• Experience with process validations (IQ-OQ-PQ), Lean Sigma, 6S.
• Strong in Statistics (process capability, CPK, DOE's, Normality, Hypothesis Testing).
• Demonstrated proficiency in written and verbal communication, including creating and delivering presentations
• Advanced skills in critical software applications, such as Microsoft Office and Solidworks
• Expertise in data and problem analysis, creative problem solving and design thinking.
• Tooling and Equipment design a plus.
• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements)
• 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.
• There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)
• Employee may be required to lift objects up to 25lbs or more.

• The anticipated base pay range for this position is $100,000 to $172,500 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 of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits