|Role Type||Fixed Term Contract|
Design Assurance Engineer II
Job ID: JOB-13200
Design Assurance Engineer II – 12 Month Fixed Term
Our clients Design Assurance Department focuses on providing Quality support across all aspects of PDP from pre-market product development to post market product surveillance. As a Design Assurance Engineer is directly involved in the design process to ensure the performance and safety of the devices our client is developing, is assured, and maintained throughout the product lifecycle.
A Day in the Life of:
- You will serve as extended team member on a PDP Project representing the Design Assurance function and will report dotted line to the quality lead on the project.
- You will prepare test method validations, design verification and shelf-life protocols / reports.
- You will be responsible for keeping abreast of industry best practice with respect to product design.
- You will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
- You will be required to liaise with departments, both internally and externally to build strong collaborative partnerships.
- You will be required to provide Quality input into new product development, process improvements and change control.
- As required, you will support cross functional teams to design protocols to ensure that new products/product changes are adequately evaluated/tested with respect to standard requirements.
- Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
- Completes risk analysis studies of new design and processes.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Ensures that corrective measures meet acceptable reliability standards.
- Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
- May develop mathematical models to identify units, batches or processes posing excessive failure risks.
- As necessary, proposes changes in design or formulation to improve system and/or process reliability.
- May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.
Desired Skills and Experience
Key Skills & Experience
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
- Requires a bachelor’s degree L8 (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- You are experienced to a competent level within Medical Device product design.
- Initiates and Leads Change, Collaborates and Creates Alignment,
- Drives Accountability and Thinks Critically and Makes Sound Decisions are a must.
- Excellent communication and ability to influence is critical to the role. You must be fluent in English, both in writing and speaking.
- The role is a day shift role. Flexibility to travel <10% of time desirable.
For further information on this role please contact Katie Kilbane on 086 1283368 / firstname.lastname@example.org
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