Senior Manufacturing Engineer (Laser Cutting)

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.

• 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.

Market Range: $113,000 - $141,000

Exact compensation may vary based on skills, experience, and location.

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits:Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer