Design Assurance Engineer - IVDR

About Abbott

Abbott is a global healthcare leader, we are 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.

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 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 Design Assurance Engineer that will strengthen the team through implementation of best practice design controls within our projects.

The Design Assurance Engineer role will be instrumental in shaping the NPI Project deliverables to support our IDEM new product development pipeline. They will provide direction to and ensure compliance across all our Core Teams and Extended Teams – R&D, Marketing, QA, RA, Clinical Operations and Manufacturing.

The specific role initially will be focused on a number of exciting new product development opportunities and participate on cross-site or cross Business Unit Core Teams to ensure standardisation of project deliverables in compliance with best-in-class design controls. Please note this position is a 12 month FTC

Responsibilities and Duties

• Promotes the awareness of regulatory and customer requirements throughout the organization.
• Remediation of current Design Control procedures and practices across sites to standardise to “best in class” design controls. Liaise with quality systems and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization.
• Deployment 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.
• Support new test development and appropriate test method validation.
• Provision of on-going 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 labelling, attend at design reviews, coordinate and facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
• Escalate where appropriate design control concerns/ issues in a timely manner to ensure project schedule maintenance.
• Design Control Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO).
• Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader.

Requirements

• Primary Degree level qualification in Science, Engineering or Technology, plus 2-3 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. 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.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.