Design Assurance Engineer II

Smiths Medical   •  

Plymouth, MN

Less than 5 years

Posted 241 days ago

This job is no longer available.

SMNA00449

Job Description

  • Opportunity to lead design assurance initiatives with new product introductions and marketed product advancements within Smiths growing hospital and ambulatory infusion business unit.
  • Provide functional leadership to project team members with a high level of personal accountability, employee engagement, and value-added support to cross-functional partners.
  • Ensure adequate design assurance engineeringsupport of new product development to drive robust designs and support the life-cycle maintenance of product risk and design documentation.
  • Oversee project team compliance to procedures and global quality system / regulatory requirements.

 

Duties and Responsibilites

  • Ensure Smiths Medical new product introductions and product change activities are in compliance with applicable FDA/EU regulatory requirements and Smiths Medical Policies and Procedures.
  • Support rigorous planning activities in relation to design control and risk management deliverables.
  • Assure organizational understanding and compliance of design quality and risk management requirements and standards.
  • Ensure disciplined execution of business unit product changes.
  • Ensure conformance to industry related regulations within the framework of Smiths Medical product and sustaining development processes.
  • Support deployment of internal development procedures including Design Control, Risk Management, Post Market Surveillance, and Statistical Techniques to the product development teams.
  • Interact and form constructive working relationships with all levels of leadership within Global Quality and Regulatory (GQR), Global Product Management (GPM), R&D, Advanced Manufacturing Engineering (AME), Systems Engineering, Sourcing, Operations, and Service/Repair.
  • Other duties as assigned with or without accommodation.

Required Skills andExperience

  • 4yeardegree in engineering or associated scientific discipline.
  • 3 - 6years experience in Quality or Design Engineering position.
  • Complete understanding and wide application of technical principles, theories, and concepts in the engineering field.
  • Proficient at problem solving and analytical techniques such as Is/Is Not Matrix, Fish Bone Diagram, Concentration Diagrams, Contradiction Matrix and Design of Experiments (DoE).
  • Proficient in use of statistical analysis and associated tools (e.g. Tableau, Minitab, Statistica).
  • Strong comprehension and demonstrated ability to apply critical regulatory standards to procedural updates and project deliverables (FDA CFR 820, ISO13485, ISO14971, INCOSE HB

 Abilities:

  • Ability to establish and maintain effective working relationships with internal team members and external stakeholders.
  • Ability to work with integrity and build trust.
  • Ability to critically review and interpret technical documentation.
  • Ability to lead team members and transfer knowledge of CtQ and other Quality tools and techniques.
  • Ability to clearly convey ideas and concepts verbally, in writing, and via presentations.
  • Ability to handle multiple priorities and consistently meet deadlines through effective time management skills.