Design Assurance Engineer

This is an opportunity to be part of the Quality function for one of the most innovative and advanced medical device manufacturing companies in the business. We are experiencing tremendous growth, even during a down market and are looking to build the quality  team via this addition to the staff.

Position: The Design Assurance Engineer provides input to our contract development teams in the design of highly complex medical devices.  They ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure successful transfer of the design to manufacturing.  They are responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance.

Nature of Role: Reporting and operating under the direction and guidance of the Senior Design Assurance Engineer, this resource performs design assurance engineering work that requires full competency in all conventional aspects of mechanical engineering related to electro-mechanical, capital/disposable, fluid transfer and sterile medical devices.

Minimum Qualifications:

• Candidates must have 3-5 years of relevant experience with a Bachelors degree or higher in Engineering, or a related discipline.  
• 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.
• Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers.
• Must be able to travel occasionally to meet with customers / project teams.

Key Responsibilities:

• Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.
• Works closely with product development engineering and the client team to establish the system design specifications and product requirements.
• Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles.
• Performs and documents all engineering studies and reports to satisfy the master verification plan.
• Plans, coordinates and executes design verification testing to directly support the master verification plan, including any additional activities such as HALT/HASS and IEC 60601-1 testing.
• Participates with the engineering team to establish and review the design FMEA.
• Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment.
• Possesses a comprehensive understanding of HALT/HASS principles, IEC 60601-1 requirements, design FMEA practices, and any industry standards to ensure products satisfy all ISO 13485 requirements.
• Support various QA/RA activities including quality management, system reviews, audits, etc.

Qualified candidates should send a cover letter and resume to hrmgr@ximedica.com