The Design Assurance Engineer will support development projects as a quality core
team member, actively participating in project teams by planning, coordinating and
performing engineering actions for the project.
- Define and/or recommend design inputs and design outputs.
- Partner with Customer to identify and manage product risk throughout the
development process and sustaining efforts with the use of risk management
plans/reports, risk assessments, FMECA, and other risk management tools.
- Establish and implement methods and procedures for inspecting, testing and evaluating
components and products.
- Participate in product development process activities such as design characterization,
design verification, design validation, process validation, regulatory submissions and
other activities as needed.
- Partner with manufacturing and external suppliers to review and assess any design or
process changes that may impact the product specifications or overall performance.
- Resolve product performance issues (NCMRs, CAPAs, deviations, manufacturing process
problems etc.) with the Customer and cross-functional team members to impact on
product safety, performance and quality.
Education, Experience and Other Skills
- Bachelor’s degree with at least 7 years in medical device manufacturing and design
- Experience in product development and design controls.
- Practical knowledge of FDA Quality System Regulations, ISO 13485 and EU Medical
- Practical knowledge of ISO 14971, EN 45502, IEC 60601-1, and other product and
- General familiarity with industry best practices in electrical, mechanical, testing and
- Skilled in standard statistical methods e.g. DOE, sampling plans and measurement
Mental and Physical Requirements
- Ability to handle and be trusted with confidential and/or sensitive information.
- Ability to work in a fast-paced, constantly changing environment.
- Ability to be flexible and to handle multiple projects in an organized, timely manner.
- Ability to problem-solve, work under pressure, and to effectively manage stress.