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.
Job Description
The Design Assurance team 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 our Lateral Flow Diagnostic Devices.
We are recruiting a Senior Design Assurance Engineer to 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
* Promotes awareness of regulatory and customer requirements throughout the organisation.
* Reviews and remedies current Design Control procedures and practices across sites to standardise to 'best in class' design controls.
* Develops effective training collateral to ensure compliance to design control policies with Core Teams, Extended teams, and relevant functions within the Business Unit.
* Embeds 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.
* SUPPORTS new test development and appropriate test method validation.
* Provides ongoing risk management, design control, quality systems, and overall design assurance expertise and leadership to the Project Core and Extended teams.
* Performs technical reviews of design documentation and labelling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation, and acts 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).
* Manages a team of Design Assurance Engineers as the organisation grows and develops.
Requirements
* Primary Degree level qualification in Science, Engineering or Technology, plus 5 years of Quality Engineering/ Design Assurance 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.
* Clear demonstrated 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.