Manager
Animas Corporation, a member of the Johnson Johnson Family of Companies, is recruiting for a Manager - Product Analysis Laboratory that will be located in West Chester, PA.
Animas Corporation develops and manufactures glucose management systems that help people living with diabetes better manage their disease and live a life without multiple daily insulin injections. Animas is dedicated to helping make diabetes management easier through exceptional customer support, educational programs and product innovation. Many of the people who work at Animas are either living with diabetes or are a first-degree family member of someone living with diabetes, so it's no surprise that the company has led the way in insulin pump innovations since its first pump launched in 2000. To learn more visit www.animas.com .
The Manager - Product Analysis Laboratory will manage the failure investigation of the returned electro-mechanical medical devices that were manufactured and/or distributed by the company. Activities involve analyzing the root cause and determine failure mode for the returned products from customers and complaint analysis, including potential MDR (medical device reportable) events.
The Manager - Product Analysis Lab will provide guidance and support to investigators and technicians on new failures and deep dive failure investigation of critical and major issues. She/he will lead the failure investigation of embedded software in the programmable hardware electromechanical devices like insulin pumps.
The Manager - Product Analysis Lab will manage the escalation of product analysis outcomes to appropriate PLIM (Post launch improvement monitoring) teams and risk assessment teams, such as REB/QB, etc. She/he will lead new product requirements and specifications in anticipation of their returns for investigation. The candidate will trend failure modes and escalate using issue escalation process as needed. This individual will adhere to FDA/ OSHA/ EHS compliance standards, including those related to the handling of potential biohazards.
The Manager - Product Analysis Lab will develop and coordinate complaint investigations between Quality Assurance, Engineering, Customer Technical Support and other departments as needed to facilitate the investigation of complex complaint events. This individual will act as SME on software and hardware failure analysis activities and guide the design partners, complaints investigation and product analysis team to make the right decision for improving product reliability. She/he will deliver the failure analysis activities through technical contribution for effective investigation, root-cause and corrective action steps.
The Manager - Product Analysis Lab will effectively line manage any lab analysts and technicians by setting and periodically reviewing their goals, job titles and description. This individual will manage support to CAPA and NC etc from product analysis and reliability side. She/he will 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. The Candidate will support in providing periodic updates to senior management on the failure analysis activities. Additionally, this individual will respond constructively to change initiatives from within or outside the team. She/he will manage 1 engineer and 16 investigators/ technicians.
Qualifications
A minimum of a Bachelor's degree with 8 years related work experience is required. A focused degree in Software, Electrical, Electronic, Mechanical or Biomedical Engineering is preferred. The selected candidate must possess proficient investigative and analytical skills for electromechanical devices. Experience with embedded software is preferred. Experience in the medical device industry is preferred. Experience in a manufacturing or quality environment is preferred. Strong technical writing skills are required. Excellent interpersonal, verbal and written communication skills are required. The selected candidate must possess the ability to perform multiple tasks, executing with precision and accuracy. The ability to interpret engineered drawings of Electro-Mechanical components is required. The ability to lead the team independently and prioritize tasks is required. The selected candidate must be able to work effectively with business partners, external manufacturers, and suppliers. This position is located in West Chester, PA and requires 5-10% travel.
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