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LC/MS Clinical Diagnostics Product Development Lead

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POST DATE 9/1/2016
END DATE 1/26/2017

PerkinElmer BOLTON, ZZ

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PerkinElmer is seeking an experienced LC/MS scientist or
engineer for the role of Product Development Lead, LC/MS
Clinical Diagnostics. The Product Development Lead will
support existing and new clinical diagnostic LC/MS
triple quadrupole products for all phases of the product
life cycle under ISO 13485 and FDA 21 QSR 820 design
control processes.
The successful candidate has experience in LC/MS triple
quadrupole product development. Leading and working with
cross-functional teams, he/she will lead or participate
with cross functional groups to implement vetted and
validated technical solutions into existing or new
products, from concept through to customer support,
according to design control regulations.
* Provide leadership of the product development team
to work with cross functional teams and the research
team for new designs and technologies under ISO
13485 and FDA design control
* Work with cross-functional teams to articulate and
quantify customer needs and requirements,
translating them into product requirements and
* Create and maintain design history files (DHF) for
each medical device type or family.
* develop & execute design verification & validation
protocols in both a hands-on and supervisory
* Determine resourcing needs to carry out projects.
* Maintain and control design changes of required
design output through the company s documentation
control system; provide technical support as needed
for the Device Master Record (DMR)
* Work within the company s design control process
compliant with ISO 13485 and 21 CFR 820 requirements
* Apply risk assessment tools and methodologies,
during product development to address risk
management requirements
* Review and investigate root cause of high priority
problem issues; implement processes to reduce the
risk of similar issues in the future
* Escalation point for production support issues;
investigate, understand and assist in the resolution
* Escalation points for product and service issues;
delegate and follow through to resolution
EDUCATION/CERTIFICATION: BSc in a scientific discipline
required; PhD preferred.
REQUIRED KNOWLEDGE: Strong, hands-on background in LC/MS
triple quadrupole development; sufficient familiarity
with LC/MS data acquisition and quantitation software to
support software-oriented user needs and system
requirements. Proficiency in MS Suite including Project,
PowerPoint and Excel
EXPERIENCE REQUIRED: Minimum of 5 years of experience in
LC/MS product design/development of triple quadruple
mass spectrometers. Experience and knowledge of
developing medical device products within ISO 13485
and/or 21 CFR 820 regulated environments is highly
preferred. Experience building appropriate supporting
documentation for 510k submissions is preferred.
SKILLS/ABILITIES: Leading/Working in cross-functional
team, adhere to a Design / Change Control System, create
and maintain Design History Files, develop & execute
design verification and validation protocols/testing,
technical report writing; work with risk management
tools such as FMEAs, understand requirements for process
validation. Provide technical / engineering expertise to
assigned teams and other programs as required. Ability
to clearly and effectively communicate (verbal &
written) concepts, ideas, data, knowledge, etc., to
individuals and teams. Execute project technical work
product and deliverables as required.