About Abbott
Abbott is a global healthcare leader, committed to helping people live their best possible life through the power of health. For more than 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 the more than 160 countries we serve.
12 month FTC
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. The team supports a rapidly expanding business unit within Abbott.
To ensure we can rapidly expand our Design Assurance capability, we are recruiting a Senior Design Assurance Engineer that will strengthen the team through implementation of best practice design controls and support the organization as a whole to maintain those within our projects.
The Senior Design Assurance Engineer role will be instrumental in shaping the Design Control strategy to support our IDEM new product development pipeline. They will drive improvement in our processes, provide direction to, and ensure compliance across all our supporting organizations – R&D, Marketing, QA, RA, Clinical Operations, and Manufacturing.
Responsibilities And Duties
* Promotes the awareness of regulatory and customer requirements throughout the organization.
* Review and remediation of current Design Control procedures and practices across sites to standardize to “best in class” design controls. Liaise with quality systems and regulatory affairs personnel within the Business Unit to ensure team compliance and to drive alignment and harmonization.
* Development of effective training collateral to ensure compliance with 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.
* Support new test development and appropriate test method validation.
* Provision of ongoing risk management, design control, quality systems, and overall design assurance expertise and leadership to the Project Core and Extended teams.
* Perform technical reviews of design documentation and labeling, attend design reviews, coordinate and facilitate completion and update of design risk management documentation, and act as an 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.
* Manage a team of Design Assurance Engineers as the organization grows and develops.
* Ability to work in a matrix organization 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 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 independently.
* 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 organization. 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.
#J-18808-Ljbffr