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Job description (Tasks/Responsibilities):
Establish the Design V&V vision and strategic direction for the business
segments/product areas. Establish appropriate and effective strategies for testing, analysis,
inspection, and studies at these levels: unit and component verification;
sub-systems integration and verification; system level verification and
validation. Help to
establish the operational V&V plans on individual projects. Analyze
and verify medical device requirements and designs, including electrical,
mechanical, and software sub-systems and inter-relationships. Use
methods of statistical analysis and data to establish objective V&V
acceptance criteria and make objective decisions. Work
with engineering and operations to develop consistent test methods and
strategies at the suppliers, in design, and on the production floor.
Skill Requirements:
BS in
Engineering or Computer Science. V&V
experience in medical device or similar regulated industry. 10+
years with BS and 8+ years with MS. FDA 21
CFR 820/ISO 13485 design control experience desired. ISO
14971 (risk management) and ISO 62304 (software) standards desired. IEC
60601 series of Medical Equipment Standards desired. Ability
to provide technical leadership, make decisions, solve problems, meet
commitments, and ensure quality.
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Company Description:
Respironics, a
worldwide leader at anticipating needs and providing valued solutions to the
sleep and respiratory markets.The
company's focus is on home care, hospital, respiratory drug delivery and
international markets providing programs that manage sleep disordered
breathing, chronic obstructive pulmonary disease, asthma, infant care,
congestive heart failure and restrictive lung disorders. Globally positioned
has manufacturing facilities in several domestic and international markets.
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