Cylink Template 1b

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Biomedical Career Paths Medical Devices, In
Vitro Diagnostics, Pharmaceuticals, Bio
Technology, and more! Rich Shumway CSUF 74 VP
Quality, Arbor Surgical Technologies,
Inc. Member, CNSM Deans Advisory Council
March 2008
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Biomedical Career Paths
Todays Agenda I. Biomedical industries
introduction Medical Devices Heart Valves II.
Specific Career Paths which might be right for
you? III. Recommendations To Jump Start Your
Search
R Shumway February 2008
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Biomedical Career Paths Good News!

• Biomedical Industry In Calif.
• 230,000 jobs
• 2,600 biomedical companies
• Mainly L.A., O.C. and Bay Area
• California Healthcare Institute (CHI)
• The biggest problemis that there are
• plenty of job openings but
• limited qualified candidate availability,
• www.biospace.com today over 1,000 job
• openings in SD. OC and LA alone

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Biomedical Career Paths

• I. Biomedical Industry Types Include
• Medical Devices, In Vitro Diagnostics
• Pharmaceuticals, biologics
• Bio Technology
• Clinical Studies
• Regulatory Compliance

R Shumway February 2008
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The Three Types of Heart Valves
Bovine Pericardial Valve
Mechanical Heart Valve
Porcine Heart Valve
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No Cuff Theoretically Better Laminar Flow
through Valve

• PERIMOUNT Magna
• Model 3000

• PERIMOUNT RSR
• Model 2800

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Valve implantation in hearts
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• II. Specific Career Paths, Job Types and
  Professions
• Research and Development
• Clinical Affairs
• Regulatory Affairs
• Quality Assurance
• Manufacturing
• Sales, marketing

Biomedical Career Paths
R Shumway March 2008
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New Hire Desirable Traits Competencies

• Bachelors in Science, advanced degree, MBA
• Very good communications skills
• Problem solving capabilities
• Team building leadership capabilities
• Does the candidate have Initiative! Previous
  internship/job?

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III. 7 Key Tactical Recommendations To Jump
Start Your Career

• Know and study the biomedical businesses and key
  job types
• Demonstrate your knowledge during the job
  interviewing process!
• Keep an open minded job search strategy Break
  the Catch 22 syndrome
• Many different roads can lead to your first
  choice!

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• Summer internships/jobs are available, and are
  very valuable
• Many opportunities found through casual or
  unexpected sources always be communicating
  (family friends, neighbors, etc.)
• Use internet job search tools
• 2 of 3 new hires changed career decisions after
  summer intern work
• Top hires out of school had internship experience

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• Interview as much as possible!
• Prepare a resume no longer than one page
• Study interviewing techniques
• Practice with business friends and acquaintances
• Do not be discouraged, keep interviewing!
• Use professional staffing agencies, e.g. Kelly
  Scientific

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• Communications skills are very important
• Prepare ahead of time a list of your strengths,
  experiences, problem solving capabilities, goals
  and objectives
• Research the industry, the firm and products well
  ahead of the interview Show enthusiasm
• Consider communications skills improvement
  strategies, e.g. Toastmasters

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• Use free resources - magazines, web sites
• Medical devices industry http//www.devicelink.com
  /mddi/
• In vitro diagnostics industry http//www.devicelin
  k.com/ivdt/
• Pharmaceuticals industry http//www.devicelink.com
  /pmpn/
• www.biospace.com see Biotech Beach gt1000 jobs
• Free trade shows - MDM West January Show in
  Anaheim

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Career Fairs

• BioSpace, Inc. is pleased to present the
  DeviceSpace Career Fair on Monday, March 17, 2008
  at the Irvine Marriott in Irvine,
  CA.DeviceSpace Career Fairs give job seekers
  the opportunity to meet face-to-face with the
  region's elite science industry employers while
  presenting the opportunity to interview for
  hundreds of specialized open positions.

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• Be poised, confident, and persistent
• Shortages of science graduates are growing!
• Firms and people really do want you to succeed
• Hiring people are extremely busy, do not
  misinterpret lack of response as a negative for
  you
• One common key tactic - Be persistent, patient
  and do not get discouraged!

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• II. Specific Career Paths, Job Types and
  Professions
• Research and Development
• Clinical Affairs
• Regulatory Affairs
• Quality Assurance
• Manufacturing
• Sales, marketing

Biomedical Career Paths
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• Research and Development
• RD Research and Develop new life saving
  biomedical technologies
• Scientist/Engineer/Research Associates,
  Scientist/Engineers I, II, Senior, Staff,
  Principal, Distinguished
• Engineering Managers, Directors, VPs
• Plus - Excellent salaries, technically
  interesting work, clinician interfacing, Located
  at Corporate HQ
• Minus - MS, PhD strongly preferred, Engineers
  highly sought after, very competitive
• Median Salary 85,000 (75,900 lt5 yrs exp.)
• MDDI 12/2005 Salary Survey

Biomedical Career Paths
R Shumway March 2008
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Biomedical Career Paths
Clinical Affairs Clinical Research Associates,
I, II, Senior, Staff, Principal, Distinguished,
Clinical Research Managers, Directors,
VPs Conduct animal and human clinical studies,
monitor clinical trials, gather data and perform
statistical analyses, negotiate contracts with
our clinical investigators Plus- Excellent
salaries, CRA certification programs are
excellent, BS/BA is good Minus- MS, PhD, MD
strongly preferred Median Salary -91,400 ,
(59,700 lt5 years experience) MDDI 12/2005
Salary Survey
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Biomedical Career Paths
Clinical profession web sites Association of
Clinical Research Professionals http//www.acrpnet
.org Society of Clinical Research
Associates http//www.socra.org/
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Biomedical Career Paths
Regulatory Affairs Manage Product Registration
and Approval Processes Guide new drugs, devices
or other products through complex approval
processes. Prepare technical documents for
submission to regulatory agencies, and know
requirements of regulators. Regulatory
Associate, Senior, Manager, Director, VP Plus-
Excellent salaries, RAC certification excellent,
Bachelors required Minus- Administrative in
nature Median Salary - 91,400, (59,700 lt5 years
experience) MDDI 12/2005 Salary Survey
R Shumway March 2008
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Biomedical Career Paths
Regulatory Affairs Professional Society
http//www.raps.org Orange County Regulatory
Affairs Discussion Group http//www.ocra-dg.org/
R Shumway March 2008
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Biomedical Career Paths

• Quality Assurance
• Manage product and process safety in all aspects
  of business and know requirements of regulators,
  scientific patient advocate for safety
• Coordinators, Associate
• Chemist/Microbiologist/Biologist, I, II, Sr,
  Principal
• Engineers I, II, Senior, Staff, Principal,
  Distinguished
• Supervisors, Managers, Directors, VPs
• Plus- Bachelors required, variety of positions,
  good for investigative nature, great
  certification programs
• Minus- Problem focus, driving improvement,
• Median Salary - 75,000, (69,400 lt5 years
  experience)
• MDDI 12/2005 Salary Survey

R Shumway March 2008
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Biomedical Career Paths
American Society of Quality (ASQ), Professional
certifications Certified Quality Technician,
Certified Quality Engineer, Certified Quality
Auditor, Certified Quality Manager ,
www.asq.org Juran Institute, www.juran.org, Asso
ciation for the Advancement of Medical
Instrumentation (AAMI), www.aami.org,
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Biomedical Career Paths
Manufacturing Manage product manufacturing,
manage work force, material flow, product cost
structure, facilities, environmental
controls Associate I, II, III, supervisor,
Manager, Director, VP Plus- Most numerous
opportunities, Bachelors required, excellent path
to learn management Minus- Focus on existing
product manufacturing, cost reduction Median
Salary - 84,200,(73,000 lt5 years experience)
MDDI 12/2005 Salary Survey
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Biomedical Career Paths

• III. Biomedical Industry Types Include
• Medical Devices, In Vitro Diagnostics
• Pharmaceuticals, biologics
• Bio Technology
• Clinical Studies
• Regulatory Compliance

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Biomedical Career Paths

• 1. Medical Devices, In Vitro Diagnostics
  Companies-
• Devices used in medical treatment, from a
  cardiac pacemakers to a wheelchair - Test and
  reagents kits and systems used in diagnostic
  evaluations Examples
• Replacement heart valves

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Medical Industry Career Tracks

• 1. Medical Device Industry
• Heart valve Systems
• Edwards Lifesciences, Irvine www.edwards.com
• Medtronic, Irvine , www.medtronic.com
• Arbor Surgical, Irvine, www.arborsurgical.com
• 3F Therapeutics, Irvine, www.3ftherapeutics.com
• In Vitro Diagnostic Systems
• Beckman Coulter Inc, Fullerton, www.beckman.com
• Bone replacement
• Interpore International, Irvine,
  http//www.interpore.com/
• Isotis Orthobiologics Irvine, www.isotis.com
• Vascular Stents
• Edwards Lifesciences, Irvine www.edwards.com
• Cordis Webster Inc., Diamond Bar,
  www.jnjgateway.com/
• Intraocular lenses
• Advanced Medical Optics, Irvine, www.amo-inc.com
• Alcon, Irvine, www.alconlabs.com

R Shumway February 2008
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Biomedical Career Paths

• 2. Pharmaceuticals, Biologics Companies-
• Products are usually drugs if they achieve
  therapy through chemical action or by being
  metabolized by the body, Examples
• Intravenous therapy drugs
• Neurological Dermatological drugs
• Cancer/Chemotherapy drugs
• Pain Therapy drugs

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Medical Industry Career Paths

• Intravenous, Nutritional and Biological
  Pharmaceuticals
• Baxter Healthcare, Los Angeles, www.baxter.com
• BBraun McGaw , Irvine, www.bbraunusa.com
• Biotechnology Pharmaceuticals
• Amgen, Los Angeles, www.amgen,com
• Genentec, S. San Francisco, genentecresearch.com
• Ophthalmic Pharmaceuticals
• Allergan, Irvine, www.allergan.com
• Generic Pharmaceuticals
• Watson Pharmaceuticals, Carona,
  www.watsonpharm.com
• Pharmaceutical/biotechnology industry, see
  Biotech Beach
• http//www.biospace.com
• ACADIA Pharmaceutical
• A

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Biomedical Career Paths

• 3. Bio Technology Companies-
• Biotechnology involves the use by industry of
  recombinant DNA, cell fusion, and new
  bioprocessing techniques
• Recombinant DNA medicines
• Genechip arrays for integrated DNA analysis

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Medical Industry Career Paths

• Bio Technology Companies-
• Amgen, Los Angeles, www.amgen.com
• Affimetrix, Santa Clara, www.affymetrix.com
• Ligand Pharmaceuticals Inc., San Diego,
  www.ligand.com
• Gen-Probe Incorporated, San Diego,
  www.gen-probe.com/
• Baxter BioScience Corporation, West Lake Village,
  www.baxter.com
• Pharmaceutical/biotechnology industry,
• See Biotech Beach-company listing and current
  biotech job listing at
• http//www.biospace.com

R Shumway March 2008
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Biomedical Career Paths

• 4. Clinical Services Companies or Clinical
  Research Organizations (CROs)
• A clinical trial (also clinical research) is a
  research study in human volunteers to answer
  specific health questions.
• Pharmaceutical, biotechnology and medical device
  companies, who call upon Clinical Research
  Organizations (CRO) resources and expertise to
  help bring new treatments to patients quickly and
  safely.

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Medical Industry Career Paths
National Institute of Clinical Research,
www.nicresearch.com Beardsworth,
www.beardsworth.com Covance , www.covance.com
Cato Research Ltd. , www.cato.com CroMedica,
www.cromedica.com PRA International,
www.prainternational.com Inveresk Research
Group, www.inveresk.com Medical Technical
Research Associates, www.mtra.com SciAn Research
Services, www.scian.com Omnicare Clinical
Research, www.omnicarecr.com Synteract, Inc.,
www.synteract.com TherImmune Research
Corporation, www.theimmune.com Quintiles, Inc.,
www.quintiles.com Association of Clinical
Research Organizations, http//www.acrohealth.org/
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Biomedical Career Paths
5. Regulatory Compliance US Food and Drug
Administration (FDA) LA District office is in
Orange County! 19701 Fairchild, Irvine, CA
92612-2506 Products FDA Regulates Food Drugs Med
ical Devices Biologics Animal Feed and
Drugs Cosmetics Combination Products Radiation-Emi
tting Products
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Biomedical Career Paths
Regulatory Compliance http//www.fda.gov/jobs/ US
Food and Drug Administration (FDA) LA District
Office, Irvine, CA.                 Biologist
                                 Chemist
                                 Consumer
Safety Officer                                 
Engineer                                 
Information Technology Specialist
                                 Medical
Officer                                 
Microbiologist                                 
Pharmacologist                                 
Statistician FDA Job Questions?
quickquestions_at_psc.gov Contact Rockville HR
Center 1-888-478-4340
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Biomedical Career paths
Regulatory Affairs Professional Society
http//www.raps.org Orange County Regulatory
Affairs Discussion Group http//www.ocra-dg.org/
R Shumway March 2008