Staff Manufacturing and Transfer Engineer
Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: November 18, 2021
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.
The Staff Manufacturing Transfer Engineer will be responsible for
management of the contract manufacturer/external partners as well
as the implementation and validation of manufacturing lines for
Shockwave products. Work closely with cross functional teams to
ensure manufacturability, achievement of project, quality & cost
targets. Develop manufacturing documentation (specification,
drawings) to support build and testing, and directly work with
manufacturing/Contract manufacturers/external partners to build
prototypes, pilot, and production instruments as appropriate.
Troubleshoot and implement changes that improve manufacturing
quality and product performance via activities such as historical
data and failure analysis, test design, documentation, and
validation of equipment and process changes.
Essential Job Functions
- Act as the primary technical point of contact; work with our
Contract Manufacturer/external partner to transfer and scale SW
product manufacturing process.
- Manage development transfer activities between R&D, Product
development and operations to contract manufacturer or external
- Work with local and international suppliers and manufacturing
sites to generate capability models and make vs. buy assessments
used as an input to site planning.
- Prepare and execute validation protocols and reports.
- Prepare engineering change orders and coordinates the
implementation of changes including training production staff.
- Develop and maintain process risk documentation (e.g. PFMEA)
and implement preventive and corrective actions.
- Provide expertise in project planning, timeline development and
management. Maintain project schedules and timelines.
- Monitor product quality and production rates. Ensure capacity
is appropriate for the manufacturing plan.
- Effectively utilize lean manufacturing tools for continuously
improve the flow of material and information in the factory
including factory layouts, visual management, 5S, JIT, Kanban
- Develop and implement robust cost-effective manufacturing
processes and improves product flow for both sustained and new
- Collaborate with cross-functional teams during development
phase(s) and provides inputs and recommendations for design for
- Develop, tests, and implements tools, fixtures and equipment
required for manufacturing processes.
- Support production on equipment maintenance, qualification, and
- Lead design transfer of new products to production including
establishing assembly time and yield targets, training needs and
- Assist in product failure investigations and design changes
required to improve product reliability and performance.
- Troubleshoot designs and processes when defects occur, leads
investigation to determine root cause and implement effective
containment and counter measures.
- Approve design releases to manufacturing, review engineering
documentation, and provide vendor and in-house DFM inputs.
- This position may require traveling to Asia up to 30% of the
- Bachelor's degree in Engineering or equivalent experience.
- 8 years' experience in all phases of Process/Manufacturing
development to launch for high volume commercial or medical
- Proven track record of leading a team and acting as the primary
technical interface to a Contract Manufacturer.
- Strong problem solving and analytical skills; experience with
use of statistical analysis and design of experiments for product
optimization and validation activities.
- Working experience with lean manufacturing, design for
manufacturing, design for test and test implementation.
- Proficient in 3D mechanical modeling with SolidWorks.
- Excellent organizational, verbal and written communication
skills as well as attention to details.
- Knowledge of and compliance with applicable Quality System
requirements such as QSRs, FDA, ISO, MDD and other applicable
- Experience in Program Management, use of Gantt Charts or
- Experience with implementing Lean and Lean Sigma concepts.
- Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage
R&R) a plus.
- Chinese and or Spanish language proficiency is a plus.
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: ESPP, Calm App, Pet Insurance, Student Loan Refinancing,
Spot Bonus awards
Keywords: Shockwave Medical, Inc., Santa Clara , Staff Manufacturing and Transfer Engineer, Engineering , Santa Clara, California
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