About Abbott
Abbott is a global healthcare leader, committed to helping people live their best possible life through the power of health. For over 135 years, we have brought new products and technologies to the world in diagnostics, nutrition, cardiovascular, medical devices, and branded generic pharmaceuticals that create more possibilities for more people at all stages of life.
Today, our 115,000 Abbott colleagues are working to help people live not just longer, but better, in more than 160 countries we serve.
Description
The global Design Assurance team for IDEM, the Infectious Diseases Emerging Market Business Unit, supports R&D, Marketing, Clinical Operations, RA, QA, and manufacturing functions based in Europe, Asia, and the US. The team is responsible for Design Control throughout the lifecycle of NPI projects from ideation through to product launch, including sustainment, for realization of our Lateral Flow Diagnostic Devices.
To ensure we can rapidly expand our Design Assurance capability, we are recruiting a Senior Design Assurance Engineer who will strengthen the team through implementation of best practice design controls and support the Organisation as a whole to maintain those within our projects.
Responsibilities and Duties
* Design and development of packaging labelling and labelling solutions for New Product Introduction (NPI) and legacy products, including IFU's.
* Participate in/lead cross-site, cross-function labelling related projects and activities.
* Generate project design assurance documentation and update label-related documentation as required.
* Communicate with various departments, functions, and sites within Abbott on labelling related projects.
* Development of effective training collateral to ensure compliance to design control policies with the Core Teams, Extended teams, and relevant functions within the Business Unit.
* Embed Design Assurance in all stages of the design concept and feasibility to support R&D through specification setting, test development, and provision of statistical sampling to ensure robust prototypes and design at design freeze.
* Provision of ongoing risk management, design control, quality systems, and overall design assurance labelling expertise and leadership to the Project Core and Extended teams.
* Perform technical reviews of design documentation and labelling, attend at design reviews, coordinate and facilitate completion and update of design risk management documentation, and act as independent reviewer for all design activities including design changes.
* Design Control Support for audits, including Abbott Corporate Audits and external Regulatory/Governing Body audits (e.g. FDA/WHO). Take the lead and front the team's participation in audits.
* Ability to work in a matrix organisation where project deliverables are accountable to the Program/Workstream Leader.
Requirements
* Primary Degree level qualification in Science, Engineering, or Technology, plus 5 years of Quality Engineering/Design Assurance/Regulatory Affairs work experience within a regulated environment (ISO13485/FDA).
* Formal training in Medical Device Risk Management, Process Validation, Software Validation, and problem Solving would be beneficial.
* Excellent data analysis skills.
* Proven ability to work well as part of a team and on own.
* Excellent communication skills to support virtual project requirements.
* Clear demonstrated experience in working in a diverse cultural environment.
* Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management.
* Travel pending company policy, global and country regulations to Asia and Europe.