Job Responsibilities
My primary responsibility is the assurance of the cleanliness of
medical devices destined for human and animal implantation to
correct orthopedic problems such as trauma. This requires
approximately 20 hours per week overseeing internal and external
(contract) laboratory studies to measure residue levels. This
includes time spent in method development and validation,
qualification of new laboratory equipment and reviewing data
generated from the studies. Another ten hours per week is spent
researching literature and looking for additional data related
to medical device cleanliness, toxicology and regulatory
requirements. The balance of the time is spent preparing or
delivering reports to management regarding the program and
planning future studies.
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Job Requirements
This position requires a minimum of a Masters Degree in
Chemistry and ten or more years of laboratory experience in the
medical device industry. Familiarity with regulatory
requirements (FDA, ISO, etc...) is a must. Familiarity with
cleaning technologies such as ultrasonics, chemical vapor
cleaning, RF plamsa cleaning as well as finishing operations
(electropolish, anodization, etc...) is very helpful.
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Uppers
Because of the unique nature of this job, it is generally self-directed. While
there are upper management expectations for success, the methods and means of
achieving the goals are left to the discretion of the person in this position.
The position requires some travel - both domestic and foreign and requires
frequent contact via teleconference with other manufacturing locations around the
globe.
The compensation package is above average and benefits generous.
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Downers
Like many high-tech positions, it is not unusual that multiple
high-priority projects must be coordinated and delivered
simultaneously. This may require overtime and often requires the
stress of informing an internal customer that their project will
not receive high priority. Dealing with unhappy customers is
part of the job. Diplomatic skills and a knack for planning and
organization are very useful tools in this position.
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Lifestyle
The standard work week is 37.5 hours. Ample time is provided for lunches and
flexibility in start and end times is the norm. The company has a family
atmosphere and in general, the various working groups get along well and are
effective in their jobs. There is a generous measure of respect for all
individuals and their talents. The company provides special luncheons frequently
as well as a splendid family day at nearby theme parks each year.
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Compensation
The salary levels are very competitive (upper 10% of salaries
for similarly employed persons in this industry) and the
benefits extremely generous. Base salaries begin at or about
$85,000 per year and with additional experience and education,
can easily exceed $100,000 Bonuses are calculated from a point
system that is tailored to each employee as well as performance
based increases in salaries available each year. Bonuses range
from the low thousands of dollars to well over $10,000 for
employees in similar positions.
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Advice to Jobseekers
Become familiar with industrial processes as much as possible
and develop critical analytical thought processes. Focus on the
end user (patient) with regard to safety and efficacy of the
products. Master mathematics, especially statistics and design
of experiments. Take care of your direct reports and make your
superiors look good.
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