BD (Becton, Dickinson and Company) Engineer II, Systems, Failure Analysis in Andover, Massachusetts

Job Description Summary

Job Description

Description

The Diabetes Care business unit has a long history within BD and is unique in that it focuses on one important disease state which is a threat to world health. The business unit is comprised of approximately 2,300 associates globally. The growth strategy includes strengthening our core diabetes drug delivery devices as well as enabling expansion of our diabetes care portfolio.

Within the Diabetes Care business, you will have the opportunity to play a vital role developing an exciting and innovative reliability platforms that will have a key impact in the Diabetes Care Design Process, and be a key contributor to BD's future growth. We are looking for highly innovative, passionate, and talented individual to develop, deploy, and define a sustaining successful systeme engineering and reliability program. If you're interested in being a part of this exciting strategy and state-of-the-art approach to product development excellence, and improving the lives of people with Diabetes, read on...

This role will provide direct work products associated with the Systems Engineering function within the BD Advanced Diabetes Care (ADC) R&D organization tied to the development of a new business platform for the Diabetes Care market. The successful candidate will assure the quality of the Systems Engineering deliverables and the timely delivery of system meeting customer needs, business objectives and strategic goals.

The Systems Engineer II will serve as the Systems Engineering representative on development projects for products developed both internally and externally (including OEMs, contract development and joint-ventures) with specialized focus on Failure Analysis and other R&D development and field related root cause efforts within the ADC organization.

Responsibilities:

Contributes to and directly implements systems engineering work products associated with product development efforts: Included are:

  • Drives System Level Root Cause Analysis

  • Analyzes field failures and determine root cause of failure, collaborate with R&D and create alternative approaches to eliminate the failure, choose the appropriate solution to the problem, and support implementation of the solution to improve performance in the field.

  • Analyzes complex product designs (electromechanical), user interfaces, and software applications, to determine areas of potential customer issues and influence the team to modify the design.

  • Performs failure analysis and provides analytical services in support of design, manufacturing, QA, and external customers.

  • Identifies and documents root cause of failure so that corrective actions can be initiated to prevent reoccurrence and to improve product quality/reliability.

  • Participates in cross-functional product development and customer meetings to communicate analysis results, support product development, and facilitate continuous improvement activities.

  • Drive System Level Testing

  • Lead scenario-based and ad hoc testing of system to improved design robustness.

  • Plan, schedule, conduct, and monitor testing activities including requirements verification test development, test execution, and associated verification documentation.

  • Write protocols and reports for integrated system verification and validation testing,

  • Uses statistics to analyze, summarize, and communicate test results and data.

  • Experience conducting Design of Experiments (DOEs), including Design for Six Sigma (DFSS) tool utility for design down-selection.

  • Support planning and execution of Human Factors studies to ensure design meets user needs and reduces use errors.

  • Supports Requirements Management

  • 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.),

  • Perform functional analysis, requirements allocation, and interface definition studies to translate desired features into detailed requirements into specifications. Work with the development teams to ensure the successful transformation of design elements into a final product.

  • Generate, update and manage requirements documentation to support product development.

  • Manage requirements within an enterprise requirements management tool (preferable IBM DOORS, or similar tool).

  • Apply technical standards, principles, theories, concepts and techniques to design products and systems.

  • 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,

  • 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.

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.

You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within specialist expertise and project management.

Professional Qualifications:

  • B.S in Systems Engineering, Biomedical Engineering, Physics, Mechanical Engineering, or Electrical Engineering. Advanced degree desired.

  • Minimum of 3 years industry experience (or combination of equivalent education and 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.

  • Hands-on experience with phase gate type product development processes and FDA QSR based Design Controls. Experience with Medical product development or other highly regulated environments highly preferred (ISO requirements and GMP guidelines, and manufacturing scale-up processes is a plus).

  • Experience with the complete product lifecycle from concept formation through verification/validation, transition into manufacturing and sustained support is essential.

  • Experience with Enterprise Requirements Management tools.

  • 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).

  • Sound understanding of product development processes and techniques for complex integrated Hardware/Software systems requiring high availability or reliability

  • Experience working with engineering and other professionals in a cross-functional matrix organization.

  • Candidate has demonstrated laboratory experimentation skills including, machine control, automated data acquisition, and data analysis.

  • Candidate works independently, is a key problem solver, and interacts with internal and external groups to procure required materials and services.

  • Candidate will have a logical approach to the solution of problems and to the product development process with the capacity for original thinking.

  • Strong self-management, prioritizing and multi-tasking skills to work within tight deadlines.

  • Excellent oral and written communication skills. Clear/Concise documentation and correspondence during project execution. Experience with Technical Writing.

  • Candidate is a team player by nature with the ability to work independently with a result-oriented ‘can-do’ attitude.

  • You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within specialist expertise and project management.

Personal Characteristics:

• Passion for technology and product development.

• Strong communications skills, written and oral.

• Strong technical skills.

• Strong interpersonal and influence skills.

• Strong technical judgment.

• Strong communication skills.

• Team orientation.

• Developing skills in project planning and leadership.

• Developing understanding of disciplined and product development processes, regulatory and quality requirements.

• Strong motivational fit.

• Strong fit with BD values.

• Ability to function well in a high pressure, fast-paced environment with an appropriate sense of urgency.

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Primary Work LocationUSA MA - Andover

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status