The Senior Design Assurance Engineer provides leadership and input to our contract development teams in the design of highly complex medical devices. They ensure that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and help to ensure successful transfer of the design to manufacturing. They are responsible for accurate and independent generation and evaluation of Design History File documentation and overall Quality System compliance. They also help guide and mentor other team members in a collaborative environment.
Nature of Role: Reporting to the Head of Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of design assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.
- Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations
- Experience in Risk Management Planning, UFMEAs, DFMEAs, EV, DV, MSAs and ideally PFMEAs, Process Verification & Validation, and Supplier Quality
- Must be able to delegate tasks as lead when there are multiple design assurance members on a program
- Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, vendors, partners, and customers
- Must be able to travel occasionally to meet with customers / project teams
Education: Bachelors Degree or higher in Engineering, or a related scientific discipline.
- Experience: 6-10+ years of relevant experience.
- Responsible for establishing, communicating, and mitigating risk throughout the product development process
- Support growth and provide mentorship to junior design assurance team members. Be a leader within the design assurance group.
- Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance to customer and regulatory requirements
- Provides Quality Systems and Design Control guidance to cross-functional development team(s) in approach to verification and documentation tasks
- Create, manage, and/or execute test objectives, test plans and schedules - coordinate test resources for engineering and design verification. Complete test reports.
- Coordinate and support execution of supplier qualification activities
- Participate in design reviews
- Review and revise Quality Management System documentation to keep current with industry standards
- Support internal and external audit activities