- 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
- 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.