Senior Design Assurance Engineer
1 day ago
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.
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 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 Organisation 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 organisation – 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 across our Manufacturing Plants, and partnering with our R&D teams to support the design control process to deliver the required design phase outputs.
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 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.
- 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.
- 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.
- 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 are the organisation grows and develops.
- 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 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. 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.
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