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Job Summary
- Company
- NxSTAGE Medical Inc
- Location
- Lawrence, MA 01843
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
Director, Software Development
About the Job
The incumbent will direct efforts in the areas Information Process and System Development, Data Processing, and System Operations related to the design, production, and operation of NxSTAGE Medical’s products.
Introduction:
NxStage is an Equal Opportunity Employer
The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxSTAGE Medical, Inc. maintains the right to modify this list at any time.
Specific Duties:
- Lead IT development activities required for data processing of NxSTAGE Medical’s family of products.
- Work closely with Director of HW/SW to insure that NxStage Medical products can integrate with NxStage IT systems, including R & D, QA / QC, Regulatory, purchasing, suppliers, materials planning and inventory control, accounting, manufacturing, test operations, contract manufacturing, shipping and receiving, service depot, and distribution.
- Integrate NxStage Medicals’ System One Products IT with customer IT systems.
- Integrate NxStage Medicals’ System One Products IT with ICU/CCU Monitoring Systems.
- Participate in the detailed design of the NxStage System One IT activities.
- Support development of NxSTAGE Medical’s standard operating procedures in the areas of design, operations and quality assurance.
- Ensure all systems and data are protected according to relevant SOPs.
- Follow Design Control SOP’s for IT projects and programs.
- Work with Quality Assurance and Research and Development to maintain an approved internal Quality System that meets the requirements of cGMPs, QSR and ISO 9001.
Education & Qualification:
B.S. in Engineering or Computer Science
Requirements:
- B.S. in Engineering or Computer Science
- 10+ years experience in Information System Design, Development and Operations.
- Experience in leading projects with technical and business teams.
- Experience with product development process, medical devices is preferred.
- Experience in business operations and management is preferred.
- Working knowledge of IT hardware, software languages, software development systems, databases, and data communication standards.
- Ability to function at all levels of design, development, test, and project leadership.
