Jim Niederjohn
April 2, 2014
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Discuss the role that engineers play in the
medical device industry
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Jim’s Background
◦ Education
◦ Career History
◦ Medical Devices & Projects
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Medical Device Engineering
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Advice
◦ Engineering Roles & Responsibilities
◦ How to develop and release a medical device to
market
◦ Career
◦ College
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Questions
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Moved to Newark, CA in 1984
Graduated from Newark Memorial High
School in 1990
Graduated from CSU Chico in 1994
◦ BS Mechanical Engineering
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Graduated from Santa Clara University in
2000
◦ MBA
A *medical device is "an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other
similar or related article, including a component part, or
accessory which is:
 recognized in the official National Formulary, or the United
States Pharmacopoeia, or any supplement to them,
 intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or
 intended to affect the structure or any function of the body
of man or other animals, and which does not achieve any
of its primary intended purposes through chemical action
within or on the body of man or other animals and which
is not dependent upon being metabolized for the
achievement of any of its primary intended purposes."
*http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm
‘00
Startup
95
CRYOVASCULAR
SYSTEMS
Acquisition
Big
company
’05
Acquisition
’10
‘15
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Manufacturing Engineer (1994 – 1998)
◦ Support all activities related to building product
◦ Make sure that the production line is meeting
throughput and yield goals
◦ Skills developed
 Product assembly knowledge
 Problem solving / troubleshooting – root cause
analysis
 Fixture Design
 Process Development & Optimization
 Design of Experiments (DOE)
 Manufacturing Documentation
 Engineering Change Orders (ECO)
 Product non-conformities and dispositioning
 Protocol and report writing
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R&D Project Engineer (1998 – 2001)
◦ Perform development activities to release products to
market
◦ Skills developed
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Component design
Injection molding familiarity
Project planning / Schedule development
Coordination of activities with other team members
Product Qualification familiarity
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Biocompatibility testing
Sterilization Validation
Design Verification (DV) testing
Accelerated Aging DV testing
Design Validation testing
Manufacturing Process Validations
Packaging Validation
 Regulatory requirements for gaining approval
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R&D Manager (2001 –2003)
◦ Project Manager responsible for releasing products
to market
◦ Supervise team of R&D engineers & technicians
◦ Lead team of cross functional resources
◦ Skills developed
 General Project Management
 Getting “buy in” on decisions
 Setting expectations when working with others
 Holding individuals accountable
 Developing (Coaching & mentoring) team
CRYOVASCULAR SYSTEMS
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Manufacturing / Project Manager (2003 –2007)
◦ Production supervisor responsible for achieving
manufacturing goals
◦ Supervise production operators and mfg. engineers
◦ Oversee development of Next Generation Device
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Process Development Manager (2007 – 2009)
◦ Manage team of process development engineers and
technicians
 Develop manufacturing processes for new products
 Perform all manufacturing deliverables to qualify device
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R&D Manager (2009 – present)
◦ Manage team of R&D Engineers and technicians
 Develop and release new products to market
◦ Employee Career Development
◦ Skills developed
 Design For Manufacturability
 Larger scale program management
 Strategic level planning for product pipeline
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“Off Pump” Coronary Artery Bypass (OPCAB)
Grafting – Minimally Invasive approach
Stabilizer
Blower / Mister
Xpose
Coronary Shunt
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Cryoplasty Catheter
◦ “Cooling therapy”
treatment for blocked
leg arteries
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RF Ablation Catheter
◦ Treatment to destroy
small areas of heart
tissue to prevent
abnormal heartbeats
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UROLIFT System
◦ Deliver implant(s) to
relieve prostate
obstruction and open
the urethra directly by
retracting the
obstructing prostatic
lobes
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MitraClip – Percutaneous mitral valve repair
◦ Treatment of Mitral Regurgitation (MR) - blood flows
backward from the heart’s left ventricle to the right ventricle
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MitraClip System
MitraClip
Research & Development Engineer
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Research: Identify a clinical need and
evaluate concepts to meet need
Development: Develop a concept into a
device and release to market
- Solid modeling (CAD) to design parts
- Build & test prototypes
- Interfacing with customers
(physicians)
- Solving technical issues
- Qualification testing of product
Sustaining: Run the business design
changes to existing products
- Corrective and Preventive Action
(CAPA) projects
- Same as Development (above)
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Manufacturing Engineer
Sustaining: Support manufacturing line to
achieve throughput and yield goals
- Address manufacturing line down
issues
- Continuous improvement projects to
reduce costs (improve cycle time,
reduce # of rejects, etc.) & improve
reliability
New product support: Develop
manufacturing processes to support new
product development
- Fixture & equipment design
- Process capability studies / DOE’s
- Qualification testing of processes
- Developing manufacturing
documentation
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Quality Engineer
Sustaining: Audit and monitor the quality
of product built to ensure that it is
meeting the customer’s expectations and
all the internal requirements
- Address non-conformities with
components and assemblies
(incoming inspection & production)
- Monitor product performance based
on complaint analysis
- Corrective and Preventive Action
(CAPA) projects
- Support audits by regulatory bodies
Projects / New Products: support
development teams who are making
design / process changes
- Compliance to internal procedures
for making changes
- Risk Management / Failure Mode
Effects Analysis
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Supplier Quality Engineer
Sustaining: Audit and monitor supplier
performance and ensure that they have
capable processes that produce
components that meet all the
requirements
- Address line down issues related
to component issues
- Perform supplier audits
Projects / New Products: Develop and
qualify suppliers for design changes /
new products
- Develop robust and capable
inspection methods
- Supplier capability assessments
- Qualification testing of supplier
processes
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Project Manager
Manage activities to achieve program
goals
- Develop and execute on project
plans to achieve project timeline
- Facilitate cross functional team
activities
- Manage high risk activities related
to the project and develop plans to
address
- Communicate project status to
management
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5 Design Control Phases
◦ “PASS” gates to move on to the next phase
Concept
Development
• Define clinical need
• Identify goals
• Identify and evaluate
concepts
• Recommendation for
further development
Design Freeze
• Finalize
specifications
• Converge to one
concept
• Finalize design
and show evidence
of achieving
requirements
Design
Verification &
Validation
• Complete
functionality
testing
Manufacturing
Readiness
• Complete full
process validation
testing
Market Launch
• Complete all
design control
requirements
• Gain regulatory
approval
• Build product for
launch
Early Years (1st couple of years out of school)
 Be a sponge – learn as much as you can!
 Set daily / weekly goals for yourself (i.e. complete task X
by Friday) & prioritize based on importance
 Put your personal life “on hold” when you are working
 Be clear on your manager’s expectations and understand
what is important to him/her
 Be pro-active and do more than what is expected
 Develop good working relations with the team you are
working with
 Find a mentor (engineer) and meet semi-regularly to get
input and feedback
 Don’t be afraid to make a mistake… you’ll learn from it
 Force yourself to do the things that are hard for you
 Find out what you really like to do
College
College Early Years (1st couple of years out of school)
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Be a sponge – learn as much as you can!
Set daily / weekly goals for yourself (i.e. complete task X by Friday)
& prioritize based on importance – attend classes, complete
assignments on time
Put your personal life “on hold” when you are working on school
projects
Be clear on your manager’s expectations and understand what is
important to him/her you
Be pro-active and do more than what is expected
Develop good working relations with the team you are working
your classmates
with
professor
Find a mentor (engineer) and meet semi-regularly to get input and
feedback
Don’t be afraid to make a mistake… you’ll learn from it
Force yourself to do the things that are hard for you
Find out what you really like to do
Do homework and assignments with a team of 3 to 4 people
Go to your professor’s office hours
Enjoy the college experience!