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Principal Mechanical Engineer

2 months ago

Columbus, Ohio, United States MILLENNIUMSOFT Full time
Job Title: Principal Mechanical Engineer

We are seeking a highly skilled Principal Mechanical Engineer to join our team at MillenniumSoft. As a key member of our R&D function, you will be responsible for leading the design and development of medical devices, ensuring compliance with regulatory standards and delivering high-quality products to our customers.

Responsibilities:
  • Lead the design and development of medical devices, including test method and measurement system development and validation.
  • Participate in the planning and execution of technical project work, applying engineering first principles and advanced engineering methods to gain deep understanding of technical issues.
  • Critically evaluate and analyze system performance and reliability, ensuring design space is adequately pressure-tested to satisfy user, regulatory, and business requirements.
  • Learn and implement 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 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 with mechanical emphasis, or 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 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.