Principal Mechanical Engineer

4 days ago

Franklin Lakes, New Jersey, United States MILLENNIUMSOFT Full time
Job Title: Principal Mechanical Engineer

This is a challenging opportunity for a skilled Mechanical Engineer to join our team at MillenniumSoft. As a Principal Mechanical Engineer, you will be responsible for contributing to the development of innovative medical devices and solutions.

Job Summary:

We are seeking a highly motivated and experienced Mechanical Engineer to join our team. The successful candidate will have a strong background in mechanical engineering, with a focus on medical device design and development. The ideal candidate will have a proven track record of successfully developing medical products and will be able to work effectively in a team environment.

Key Responsibilities:
  • Define, plan, and lead activities related to test method and 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, applying engineering first principles and advanced engineering methods to gain a deep understanding of technical issues and propose robust solutions.
  • Critically evaluate and analyze system performance and reliability, ensuring the design space is adequately pressure-tested to satisfy user, regulatory, and business requirements.
  • Learn and implement Design for Six Sigma (DFSS) rigor throughout the design selection and development process, leveraging empirical, statistical, and analytical tools to improve design decisions and reduce design iteration cycle times.
  • Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
  • Actively build on personal skills, expertise, and competencies, ensuring that technical lessons are reviewed, learned, and disseminated.
  • Ensure compliance with BD quality policies, procedures, and practices, as well as all local, state, federal, and BD safety regulations, policies, and procedures.
Requirements:
  • Bachelor's degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or a related field.
  • 0-3 years of post-baccalaureate professional experience supporting product development projects.
  • Experience solving problems, providing detailed insight and constructive criticism in complex situations, and foreseeing problems along with potential solutions.
  • Experience in modeling, simulations using Finite Element Methods (e.g., 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 and project manage on multiple cross-functional projects.
Desired Qualifications:
  • Graduate degree (MS) in Mechanical Engineering, Biomedical Engineering, or a 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.
  • Knowledge in common risk management techniques.
  • 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.
Competencies:
  • Excellent written and 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.

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