Manager - Reliability and Product Analysis Johnson & Johnson Family of Companies -
Inverness
LifeScan, Inc., a member of Johnson & Johnson Family of Companies, is recruiting for Manager - Reliability and Product Analysis located in Inverness.
As the market leader and maker of blood glucose monitoring systems for home and hospital use, LifeScan, Inc., a Johnson & Johnson Company, is dedicated to improving the quality of life for people with diabetes through our OneTouch® Brand of blood glucose monitoring systems. The ONETOUCH® Brand of consumer and institutional products includes portable electronic meters and disposable reagent test strips to provide accurate glucose readings, and also the software tools to transform this information into actionable health care decisions.
Responsibilities
Working within the research and development department on leading product reliability initiatives and drive product failure investigation.
Manage the reliability program for Life scan's new products by working closely with R&D Engineers and project leads at Inverness, West Chester, Milpitas and China. Drive in-house and external lab test capabilities and lead a small group of lab analysts and engineers to effectively run the meter and pump test labs.
Manage reliability assessments on product design such as Life Data Analysis (LDA), DFMEA, PFEMA, technical review for failure mode avoidance and propose changes to improve product reliability. Act as SME on Reliability Engineering and guide the R&D, Quality and Operations Engineers to make decisions on product reliability.
Manage the execution of product analysis of customers' returned LFS products, deep dive failure investigation of critical and major issues, and drive product improvements. Manage the escalation of product analysis outcomes to appropriate PLIM (Post launch improvement monitoring) teams and risk assessment teams, such as REB/QB, etc
Act as SME on failure analysis activities and guide the design partners, complaints investigation and product analysis team to make the right decision for improving product reliability. Deliver the failure analysis activities through technical contribution for effective investigation, root-cause and corrective action steps. Responsible for delivering the failure analysis report and sharing the findings with key stakeholders in the business to take appropriate actions.
Effectively line manage any lab analysts and technicians by setting and periodically reviewing their goals, job titles and description.
Manage support to CAPA and NC etc from product analysis and reliability side
Effectively work with external design partners on a global framework and drive the team to deliver to the required quality and timelines that is outlined for a project. .
Author training modules in reliability engineering and support training programs for engineers in quality, R&D and operations.
Support in providing periodic updates to senior management on reliability engineering and failure analysis activities.
Decision-making will be on identifying the right reliability tests and assessments to improve product reliability for new products.
Respond constructively to change initiatives from within or outside the team.
Manage two/three engineers, six reliability and quality engineer analysts, 1 PAL supervisor, and 6 technicians.
Qualifications
Essential
A minimum of graduate degree in any Electrical or mechanical engineering discipline
5 years of relevant / practical experience of driving reliability for electronic assemblies such as PCBs.
3 year experience of performing failure investigation of BGM products
Practical experience in Reliability Engineering methodologies such as Life Data Analysis, Reliability testing such as HALT, HASS and qualitative reliability, Design and Process FMEAs.
Desirable
CRE with extensive work experience in electronics and embedded systems reliability.
Awareness of medical device quality system regulations such as 21CFR 820 and ISO 13485
Relevant work experience in invitro diagnostic medical devices
Skills
Skills to use reliability specific software tools such as Weibull ++ 7™ and ALTA™
Good communicator both written and oral
A level of professional or technical knowledge in Reliability Engineering, failure investigation, and project management.
Relevant knowledge of microcontroller based programmable devices with embedded software.
Johnson & Johnson Family of Companies - 16 months ago
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