Manager, Manufacturing Engineering
Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: January 16, 2022
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 Manager, Manufacturing Engineering leads the efforts of
Manufacturing Engineers and technicians in support of day-to-day
production and, process and product improvement efforts for the
products released from design control (i.e., Phase 5) to market
release. Responsible for sustaining engineering, manufacturing and
equipment engineering within Shockwave, including designing,
developing, testing, and implementing processes for the ongoing
production, tooling and fixtures for capacity and productivity
improvement. Works closely with product development teams, until
successful transfer into the company's manufacturing
Oversees the day-to-day work of employees and manages their
performance and development. Develops, implements, and monitors
projects, adheres to timelines and budgets, procures capital
equipment and tooling as required to support manufacturing efforts,
and provides both technical and management leadership to maintain
product functionality as well as cost efficiencies.
Essential Job Functions
- Ensures that Manufacturing Engineering teams deliver the
highest quality products using processes which consistently meet
(or exceed) all applicable customer expectations; follows QSRs, FDA
and ISO requirements; abides by company safety policies, practices
and procedures; and consistently meets company goals, objectives,
- Oversees the day-to-day work of Manufacturing Engineering
department employees and manages their performance and development
by facilitating training and providing performance feedback and
- Integrates into cross-functional teams and cultivates a network
of support (Manufacturing, Quality, Sales, and Marketing) to
facilitate completion of assignments, utilizing external resources
- Mediates group conflicts and resolves issues between team
- Participates in and leads continuous improvement activities and
advanced problem-solving techniques.
- Works collaboratively with R&D, Quality and Production
departments to design, develop, test, and implement processes,
tooling, and fixtures.
- Collects data and analyze process performance and capabilities
for company products, including new products and products already
- Performs tolerance analyses for components, manufacturing
materials, packaging, and supplies used for in-house
- Leads effort to develop and maintain process Failure Modes and
Effects Analyses (pFMEAs) for new company processes.
- Identifies requirements, advises Operations management,
prepares proposals and acquisition arrangements, and implements
equipment and fixturing needed for development and manufacturing
- Develops and maintains documentation for design control,
product configurations (e.g., bills-of-materials), and other
Quality System requirements.
- Leads and/or actively participate in process/product
improvement projects (in cooperation with R&D and Quality
engineers and technicians). Mentor and Develop Engineers.
- Performs productivity and costing analyses (e.g., calculate
direct labor & materials costs for new products, identify and
implement cost reduction plans for existing products).
- Ensures the engineering team and other manufacturing
departments work together cohesively.
- 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 or equivalent experience.
- Ten (10) years' of demonstrated management experience in a
directly related field, preferably in a medical device
- Ability to manage resources: time, budget and people. Strong
people management skills are essential.
- Experience with process validations (IQ-OQ-PQ), Lean Sigma,
- Proficient in statistical analysis (process capability, CPK,
DOE's, Normality, Hypothesis Testing).
- Demonstrated proficiency in written and verbal communication,
including creating and delivering presentations to a variety of
- 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 such as QSRs, FDA, ISO, MDD and other applicable
- Ability to work in a fast-paced environment while managing
- Operate as a team and/or independently while demonstrating
flexibility to changing requirements.
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 , Manager, Manufacturing Engineering, Engineering , Santa Clara, California
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