Title: Staff Engineer - Systems
Location: US-Massachusetts-Billerica
Job Number: SYS00065
Overview:
Provide direct work products associated with the Systems Engineering function within BD R&D organization tied to the development of a new business platform for the Diabetes Care market. Assure the quality of the Systems Engineering deliverables and the timely delivery of systems meeting customer needs, business objectives and strategic goals.
Serve as the Systems Engineering representative on development projects for products developed both internally and externally (including OEMs, contract development and joint-ventures).
Responsibilities:
* Plans, oversees, contributes to and directly implements systems engineering work products associated with product development efforts: Included are:
* High level requirements generation based on Voice of the Customer, market research and other internal and external data sources. Establish CTQs (Critical to Quality) requirements for these systems
* Translate these high level requirements into detailed internal requirements including Product Requirements and Sub-system Requirements Specifications. Work with project teams to further translate and track these into discipline specific requirements (i.e. electrical, mechanical, software, labeling etc.)
* Work to establish and recommends product architectures that support these requirements consistent with BD Diabetes Care goals, organizational capabilities and quality and regulatory standards
* Work with the development teams to ensure the successful transformation of these design elements into a final product
* Work with the development teams to trace these requirements back to their source and forward to the elements of the system that provide them
* Ensure that development teams aggressively manage the interfaces between product subsystems to ensure that the total system meets project, company and regulatory requirements
* Actively supports quality engineers and R&D during risk management activities (utilizing tools such as Fault Tree and Failure Mode and Effects Analysis) to develop robust designs and mitigate events or conditions that could degrade system performance
* Establish criteria and methodologies for verification and validation of CTQs and all product requirements
* Write protocols and reports for integrated system verification and validation testing
* Drive, facilitate and participate in appropriate peer reviews of engineering and project work products
* Support the commercial launch of the system including product surveillance and support
* Maintain strong and positive customer interaction to strengthen the credibility of the engineering function
* Work with process improvement groups to establish effective work products and processes for Systems Engineering deliverables and standardize these across all new product development efforts
* Promote the Systems engineering function and serve as a driver for the application of a systems-oriented focus to all Diabetes Care development teams and partners
* As required, serve as a resource within the R&D organization to:
* Analyze, critique and make technical contributions to projects across the breadth of the organization. Supply critical organizational, analysis and problem solving skills to all aspects of our development programs
* Coordinate and manage complex technical development activities involving cross-functional teams working within and external to the BD organization
* Serve as a continued customer advocate
Qualifications:
*
BS in Systems,Electrical, Biomedical, Software, Mechanical or related Engineering discipline
*
Minimum of ten (10) years industry experience in the development of medical products for the professional or consumer market. Experience with product systems consisting of both devices and disposables is highly desired
*
Experience with new product development in a highly regulated environment
*
Experience with the complete product lifecycle from concept formation through verification/validation, transition into manufacturing and sustained support is essential
*
Experience with structured development and engineering processes (emphasis on systems engineering) and methodologies such as CMMI (Capability Maturity Model Integrated) and DFSS (Design for Six Sigma)
*
Experience working with engineering and other professionals in a cross-functional matrix organization
*
A proven track record of successful contribution to products, projects, processes and intellectual property
*
Abilities and experience in working globally with internal teams, outside partners and OEMs is required
*
Excellent verbal and written communication skills and presentation skills
*
Strong evidence of successful team participation
*
Strong evidence of effective planning, organization, analytical and leadership skills Strong evidence of excelling at strategic thinking with an understanding of business objectives and goals
*
Strong evidence of excelling at concept formation and concept flexibility relative to both technology issues and business issues
Job: Systems Engineering