Principal Design Assurance Engineer

Our client a global healthcare company currently seeks a Principal Design Assurance Engineer to join their team. The position is part of a team that is responsible for Design Control throughout the lifecycle of NPI projects, from ideation through to product launch including sustainment, for realization of Devices. The team supports a rapidly expanding business unit.


The Principal Design Assurance Engineer 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 Principal Design Assurance Engineer role will be instrumental in shaping the Design Control strategy to support 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 - automation, process development and global engineering to support the design control process to deliver the required design phase outputs.


Role/Responsibilities:

• Lead all design assurance activities on assigned projects.
• Promotes the awareness of regulatory and customer requirements throughout the organization.
• Development of effective training collateral to ensure compliance to design control policies within the Core Teams, Extended teams and relevant functions within the Business Unit.
• Provision of on-going risk management, design control, quality systems and overall design assurance expertise and leadership to the Project Core and Extended teams.
• 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.
• Provide Design Assurance Core Team Oversight and direction;
  • o Perform technical reviews of design documentation and labelling, attend at core team meetings and 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.
  • o Provide oversight on the development of new test methods and appropriate test method validation.
  • o Provide direction on anomalies identified in design deliverables through data-based investigation and robust corrective action.
• Design Control Support for audits including Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Take the lead and front the team’s participation in audits.
• Manage the work of a team of Design Assurance Engineers as the organisation grows and develops.
• Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader.

• 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).
• Strong technical capability. Experience as a quality lead on a medical device new product development programme would be ideal.
• 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 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.