Johnson & Johnson is recruiting for a Senior Manufacturing Engineer for Shockwave Medical Inc. located in Santa Clara, CA.

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.

• Strong knowledge of manufacturing processes related to Laser Cutting and manufacturing.
• Hands on capability to set up and calibrate laser cutting machines according to job specifications. Operate machines to cut materials such as metal, plastic, and composites
• Knowledge of materials commonly used for laser cutting.
• Knowledge of transitioning from prototyping / proof-of-concept to sustainable, repeatable manufacturing processes.
• Leads or plays a prominent role supporting product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing.
• Coordinate and maintain relationship with suppliers to ensure the delivery of superior components and services.
• Authors and executes product and system specifications, validation and test protocols and validation and test reports.
• Assesses reliability, safety, performance and risk of new designs and methodologies and insures individual and group safety when conducting all activities.
• Supports manufacturing activities, as necessary.
• Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering team to enhance manufacturability and product cost.
• Must possess strong communication skills to interface with operators, technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
• Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.
• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Support the transfer of product lines and the qualification-validation efforts.
• Evaluates existing engineering processes and recommends improvements.

• Bachelor's degree in Engineering.
• Minimum of five (5) years of experience in a medical device environment or, 3 years of experience with a Master's Degree.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
• Experience and understanding Process Validations (IQ,OQ,PQ), 6S, Lean Manufacturing, Experience working with statistics and using statistical software, Capability Studies (Cpk's), DOE's.
• Strong Knowledge of Solid modeling/CAD experience (SolidWorks preferred).
• Strong problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
• Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
• 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.

• 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