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Senior Engineer: Verification, Validation and Test Method Development

Overview

Be part of something bigger at BD. Here, you’ll join a driven, agile R&D team working in a start-up-like environment that has the backing and resources of a Fortune 500 company. In R&D, you never quite know what’s around the corner, but we can tell you that you’ll be involved in a variety of innovative and exciting projects, from developing new products to finding cost savings, and everything in between. Here, you’ll use your talent and track record for delivering technical solutions to complex problems to achieve one singular goal: advancing the world of health. At BD, you can make a true difference of one.

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Success Profile

What makes a successful Engineer Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Conceptual
  • Creative
  • Imaginative
  • Problem-solver
  • Team player

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A New Era in Healthcare

The complementary nature of BD and CareFusion capabilities make the new, combined company more relevant than ever before. It’s not just the solutions we offer, It’s also where we offer them. The global reach of the combined company can offer new solutions around the world.

Quote

Zakiyyah Walker, Staff Engineer, R&D Lean Processes

"As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from."

Michael Carrano, Sr. Program Manager, Sustaining Team Leader, R&D Project Management

"Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals."

Justyna Zielinska, Project Manager, Project/Program Management

"BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service."

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Benefits

  • Healthcare

  • 401(k) / Retirement Plans

  • Employer Matching

  • Tuition Reimbursement

  • Professional Development

  • Maternity and Paternity Leave

  • Paid Time Off

  • Compensation

  • Awards & Recognition

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Responsibilities

Job ID R-361613 Date posted 03/11/2020

Job Description Summary

Job Description

This position will contribute to a global business within BD Medical, dedicated to delivering quality and innovative solutions in Hazardous Drug Safety (HDS) business. The business is committed to maintaining its accelerated growth through portfolio diversification, differentiated offerings and geographic / market expansions, while maintaining the profitability of the core product lines. We manage a healthy portfolio of programs ranging from incremental innovation to disruptive & breakthrough opportunities enabling medication delivery solutions. Our engineers and scientists have passion for bringing innovative technical solutions to meet serious unmet clinical needs, have strong records of professional achievement, and have the desire for continuous development and growth. We strive to provide individuals with opportunities to develop skills, gain and share knowledge, understand and deliver what our customers need and build a rewarding and fulfilling career.

We are recruiting for a highly driven technical professional with a passion for problem solving and a proven track record of successfully developing medical products. Reporting to the Senior Staff Engineer / Product Lead Designer of R&D, the successful candidate has a unique opportunity to join a high-caliber global R&D team responsible for test method development, verification and validation in a growing business within BD Medication Delivery Solutions (MDS) business unit.

The incumbent will join the Verification & Validation Test Engineering team as a Senior Engineer, providing technical support to a cross-functional team. The successful candidate will be responsible for supporting product verification activities and will lead test method development activities, measurement system development & analyses, test fixture design and equipment hardware/software validation of measurement system equipment. He/she will ensure that translated product requirements are testable and measurable. The ideal candidate will also participate in executing technical and cross-functional project work which may include all phases of product development, including design and development planning, requirements definition, product development, root cause analysis, test method development, and design verification/validation.

Responsibilities include but not limited to the following:

  • Define, plan and lead activities, including, test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
  • Participate in the planning and execution of technical project work. This will involve the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
  • Collaborate with Design & Development, Systems Engineering and V&V Engineering teams to ensure that product requirements are testable and measurable.
  • Synthesize, develop, update and optimize designs that meet requirements by understanding design space with design options and tradeoffs, managing critical parameters, leverage strong engineering fundamentals and tools and integrating manufacturing principles early in the development.
  • Critically evaluate and analyze system performance and reliability and ensure the design space is adequately pressure-tested to satisfy user, regulatory and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
  • Implement DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical and analytical tools which will improve design decisions and reduce design iteration cycle times.
  • Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, usability, reliability and safety.
  • Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
  • Actively build on personal skills, expertise, and competencies. Ensure that technical lessons are reviewed, learned, and disseminated.
  • Ensure compliance with BD quality policies, procedures, and practices.
  • Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures

Minimum Qualifications:

  • Bachelor’s degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering with mechanical emphasis or related field.
  • 4-6 years of post-baccalaureate professional experience leading or supporting product development projects 
  • Experience with implementing product changes through a structured, phase-gated product development process
  • Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
  • Leadership and team building skills
  • Experience with design best practices, including advanced tolerance design, and design for reliability.
  • Working with regulatory standards
  • Strong project management on multiple projects cross functionally

Desired Qualifications: 

  • Graduate degree (MS or PhD) in Mechanical Engineering, Biomedical Engineering or related field
  • 2+ years of post-educational experience in Medical Device Design highly desired
  • Design for Six Sigma, Design for Manufacturability training / experience highly desired
  • Experience with injection molded plastics and design of high-volume disposables highly desired
  • Experience as lead in the development of medical disposable devices highly desired
  • Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies highly desired
  • Expertise in common risk management techniques highly desired
  • Experience in modeling, simulations using Finite Element Methods and sensitivity analyses
  • Experience in development using cross-functional teams ideally in a healthcare, medical technology or life sciences area highly desired
  • Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired

Competencies:

  • Excellent written & verbal communication skills
  • Ability to learn and adapt quickly to multiple and competing requests. 
  • Must be comfortable making practical assumptions with engineering justifications, where needed.
  • Ability to work independently.
  • Ability to work under pressure and time constraints.
  • Effective interpersonal and collaborative skills.
  • Deals with ambiguity, making practical assumptions with engineering justification where needed
  • Masters the technical skills, knowledge and tasks associated with the role

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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