NPD Engineer II

VitalPathSaint Paul, MN
1d$68,475 - $91,300Onsite

About The Position

At VitalPath, the role of a New Product Development Engineer II is central to our mission of pioneering medical technology. Your expertise will be paramount in orchestrating the design and development of our customers’ products and associated manufacturing processes. This role is tailored for those passionate about merging innovative design with practical application, ensuring our products not only meet but excel beyond our and our customers’ design specifications and performance criteria.

Requirements

  • Bachelor's degree in Mechanical, Biomedical, or other relevant Engineering required.
  • Minimum 3 years working in a catheter development or medical component and manufacturing environment, with a focus on product and process design
  • Demonstrated excellent written and oral communication skills
  • A working knowledge of minimally invasive medical device design, development, and manufacturing processes
  • Understanding of process validation (IQ, OQ, PQ) strategy
  • Excellent working knowledge of GD&T and Solidworks
  • Working knowledge of Minitab
  • Experience with design controls, FDA regulation, GMP, and QMS requirements
  • Must be able to work with a microscope and sit and/or stand for an extended period of time

Nice To Haves

  • Working knowledge of Six Sigma
  • Experience with lean manufacturing processes
  • Experience in defining budgets and schedules for projects
  • Understanding of machining principles and processes

Responsibilities

  • Innovative Product Design: Spearhead the development and verification of catheter designs or medical components, ensuring they meet rigorous medical standards and patient needs. Utilize advanced engineering principles to create effective, reliable, and innovative solutions.
  • Design for Manufacture: Develop and refine the design to enable efficient product flow and high yields. This includes the selection and design of equipment, tooling, and fixtures, to enhance catheter or medical component production and testing. Conduct DOE and Gage R&R, as appropriate to dial in the right process settings.
  • Create Documentation: Generate detailed documentation, including work instructions, test methods, and visual guidelines, to standardize manufacturing processes.
  • Collaborative Problem-Solving: Work closely with a cross-functional team to identify root causes of product nonconformances. Develop and implement corrective and preventative actions, leveraging your expertise to troubleshoot and refine processes.
  • Manufacturing Transition Support: Collaborate with quality and operations teams to ensure smooth transition of products to manufacturing. Provide critical Design for Manufacturability (DFM) input throughout the product development lifecycle to ensure products are optimized for manufacturing.
  • Education and Training: Train and guide support staff in the proper execution of manufacturing processes and the use of specialized tooling and fixtures, ensuring adherence to best practices and quality standards.
  • All other duties as required

Benefits

  • Comprehensive, Low Cost Health and Dental Insurance Plans Available
  • Vision Insurance
  • Health Savings Account with company contribution
  • Short and Long Term Disability
  • Supplemental insurances (short term disability, AD&D, life insurance, MN paid family & medical leave, and more)
  • Parental Leave
  • Paid Time Off
  • Minnesota Earned Sick & Safe Time
  • Paid Holidays
  • 401K with company match
  • Opportunities for career growth and advancement
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