Auto req ID 10668BR
Position Title Manager, Technical Support
Job Title: Technical Support Sr. Manager
Job Code: TSPL107
Career Band: 8
Hiring Manager: Jonathan Sahin
Provide direct supervision to Technical Applications Scientists within a business unit who are responsible for pre and post-sales technical support to customers and field personnel. Monitor operations and provide direction and training as required.
Will manage the processes and people the failure investigation of medical devices that were manufactured and/or distributed by the Company. Activities involve analyzing the root cause and determination of failure mode for the returned products from customers and complaint analysis, including potential MDR (medical device reportable) events.
Will develop and coordinate complaint investigations between Quality Assurance, Manufacturing Sciences, R&D, Field Application Specialists, Customer Service and other departments as needed to facilitate the investigation of complex complaint events.
This individual will support to CAPA and NCM from product analysis and reliability side.
This individual will adhere to FDA/ OSHA/ EH&S compliance standards, including those related to the handling of potential biohazards.
- Supervise Technical Application Scientist/s; including personnel recruitment, regular performance evaluation and monitoring for development purposes, ensuring appropriate resources are available and the effective use thereof.
- Create and maintain the budget of a Cost Center.
- Coordinate customer notification activities within business unit. Participate in Specialty Team projects/individual projects.
- Accurately record pertinent information from customer contacts. Summarize trends and technology as technical tips, FAQ’s and troubleshooting guides. Suggest and make changes to Trackwise, website, and other company managed deposits of technical information. Write and design primary support documents.
- Provide advanced technical support for escalated or higher level technical issues and customer concerns. Handle difficult customers and requests for excessive compensation. Serve as a resource regarding departmental procedures and specialty products.
- Track product related issues and escalate issues when warranted. Coordinate with and update selected business units to communicate customers’ needs.
- Continually monitor functionality of database design, standards, and implement upgrades. Assess and implement new software and resources for accessing technical information.
Nature and Scope
- Conduct and participate in training, both new product and continuing education to remain at the edge of scientific knowledge. Maintain technical acuity with appropriate product lines and services. Develop course materials and facilitate training / technical briefings with R&D, Manufacturing Sciences, Marketing, Sales, and Technical Services.
- Present technical updates, departmental updates and facilitate department meetings.
- May present technical and product information at trade shows and in customer field visits.
Position exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Directs and controls the activities of multiple projects and personnel. Performs duties independently with only general direction given on new projects. Job encounters diverse work situations involving a high degree of complexity. Works on complex problems of diverse scope where analysis of situations or data requires an in-depth evaluation of various factors. Accuracy is required in performing all functions of this position.
Requires a B.S. or B.A., preferably in engineering, life science/technical discipline in molecular biology or similar field. An M.S./Ph.D. is preferred.
- Minimum 8 years related laboratory experience required as well a minimum of 5 year related experience providing complex technical service support in a life sciences field required.
- Experience in a manufacturing or quality environment is required. Experience in the medical device industry is preferred.
- Requires high degree of technical comprehension of appropriate FDA medical device regulations, safety standards and regulatory compliance guidelines.
- Knowledge/exper ience of 21CFR Part 82 0 reg ulations, ISO-9000, ISO 13485, and H uman leukocyte antigen ( HLA ) system experience is required.
- Prior supervisory experience required, including the proven ability to lead and provide work direction. The ability to lead the team independently and prioritize tasks is required.
- Demonstrated ability to effectively solve complex problems is required. Proven success in handling difficult customers with professionalism, dignity and tact required; ability to successfully handle crisis situations preferred.
- Demonstrated ability to effectively communicate, both orally and in writing, to customers and colleagues, including detailed instruction and explanation required.
- Strong technical writing skills are required.
- Excellent interpersonal, verbal and written communication skills are required.
- The selected candidate must possess proficient investigative and analytical skills for IVD devices.
- Demonstrated ability to balance and prioritize responsibilities in accordance with business and customer needs.
- Excellent time management skills and ability to work independently required.
- Computer literacy, including spreadsheet, database, and word processing applications as well as the Internet required. Experience in Siebel, and/or E1 software is preferred .
- Proven ability to quickly learn large amounts of new, complex technical information required.
- The selected candidate must possess the ability to perform multiple tasks, executing with precision and accuracy.
- Experience with embedded software is preferred.
- The selected candidate must be able to work effectively with business partners, external manufacturers, and suppliers.
Manager has contact with internal and external customers, including all levels of management on a daily basis. Serve on cross-functional teams to provide expertise and to represent customer perspective and needs.
This position requires repetitive typing, considerable interaction on the telephone and regular viewing of a computer monitor. The use of voice is required for a significant portion of the day. Most of the other physical demands are typical with those associated with an office environment.
Occasional work in a laboratory environment is a possibility. Must be capable of observing and adhering to lab safety standards and protocols.
Life Technologies - 12 months ago
Life Technologies is a global biotechnology tools company providing premier systems, consumables, and services for scientific researchers ar...