Senior Design Assurance Engineer

Smiths Medical   •  

Plymouth, MI

Industry: Medical Equipment


5 - 7 years

Posted 371 days ago

Job Description

Opportunity to lead design assurance initiatives towards improving customer satisfaction with Smiths Medical products.  Engage others, promote and participate in new product introductions and sustaining activities with focus on Critical to Quality (CtQ) attributes and characteristics.  Opportunity to lead Smiths Medical team in use of CtQ tools and methods such as CtQ requirements flowdown from customer, design, and manufacturing processes.  Use of CtQ Tree, and statistical methods to evaluate product ability to meet CtQ requirements.     


Duties and Responsibilites

  • Assure Smiths Medical new product introductions and product sustaining activities are in compliance with applicable FDA/EU regulatory requirements and Smiths Medical Policies and Procedures.
  • Lead CtQ efforts during new product introduction process to assure robust and efficient launches of new and innovative healthcare products.
  • Support deployment of internal development procedures including Design Control, Risk Management, Design Verification, Design Validation, and Statistical Techniques to the product development teams.
  • Assure conformance to industry related regulations within the framework of Smiths Medical product and sustaining development processes.
  • 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), Sourcing, Operations, and Service/Repair.
  • Support review of Agile Change Requests and Change Orders for new and sustaining products
  • Other duties as assigned with or without accommodation.

Required Skills andExperience

  • 4 yeardegree in engineering or associated scientific discipline
  • Minimum of 6 years experience in Quality or other scientific related position
  • General knowledge and understanding of Critical to Quality principles with proficient understanding of DFSS, DMAIC, and CPM tools and methods.
  • 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).
  • 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.