Mechanical Engineer 3
  • Franklin Lakes, New Jersey, US
  • +914043515100
419 Days ago
Job Description

Overview:

  • The incumbent will join the Verification & Validation Test Engineering team as a Contract Engineer, providing technical support to a cross-functional team. The successful candidate will be responsible for supporting product verification activities and will assist test method development activities, measurement system development & analyses, test fixture design and equipment hardware/software validation of measurement system equipment. 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.
  • 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.
  • Learn and eventually 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.
  • Learn and eventually 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.
  • 0-3 years of post-baccalaureate professional experience supporting product development projects
  • Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
  • Experience in modeling, simulations using Finite Element Methods [Eg: ABAQUS] and sensitivity analyses
  • Experience with design best practices, including advanced tolerance design, and design for reliability.
  • Working with regulatory standards
  • Ability to multi-task, project management on multiple cross-functional projects

Desired Qualifications:

  • Graduate degree (MS) in Mechanical Engineering, Biomedical Engineering, or related field
  • 0-2+ years of post-educational experience in Medical Device Design
  • Fundamental knowledge of Design for Six Sigma, Design for Manufacturability
  • Knowledge of injection molded plastics and design of high-volume disposables
  • Development of medical disposable devices
  • Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies highly desired
  • Knowledge in common risk management techniques 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 ass
Industry
  • NA

Required Skills
  • Mechanical Engineer 3

Experience
  • 3 Years of Experience

Salary
  • NA

Working Hours / Week
  • 40h