Engineer III, Quality
About The Position
This role supports Senior Engineers with platform and partner needs, ensuring product quality targets are met through the design and implementation of test plans. The position provides statistical guidance, including sample size selection, test method validation strategies, and defining evidential requirements for risk management. It also guides the identification and traceability of requirements, ensures platform requirements are defined and verifiable, and sponsors robust execution of Risk Management activities. The role ensures requirements are appropriately defined and tested, guides process and product development through data analysis and inspection plans, and provides analysis for investigations and corrective actions. Additionally, it incorporates assessments of operational performance and product quality into risk management documentation, proactively communicates project risks and status, and manages other job functions and duties as required.
Requirements
- Bachelor’s Degree in Engineering discipline
- A minimum of 4 years of device/combo product design and development experience, working in a highly regulated environment, quality, manufacturing, or engineering
- Intermediate knowledge of Risk Management, device manufacturing, and statistical analysis techniques including use of Minitab (or comparable) software
- Possess a good balance of basic technical expertise, analytical thinking, and communication skills for resolving issues internal and external to the organization
- Comfortability in speaking with external partners regarding business needs
- Competent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab)
- Apply solid cognitive ability to collecting, processing, and disseminating information
- Ability to have a positive impact on others in support of company goals and a healthy work environment
- Ability to adapt behaviors and activities during times of change and handle unexpected situations with little to no guidance
- Exemplifies flexibility and resourcefulness; responds deftly to a variety of challenges and situations
- Excellent time management skills
Nice To Haves
- ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certifications
- Quality Engineering Experience
Responsibilities
- Support Senior Engineers with any platform and partner needs
- Ensure product quality targets are achieved by supporting the design and implementation of test plans
- Provide the design team with statistical guidance including sample size selection, test method validation strategies, and defining evidential requirements to support risk-management claims and mitigations
- Guide the identification and traceability of requirements from Feasibility through Design Release
- Ensure platform requirements are defined, verifiable, and are not redundant
- Sponsor a robust execution of Risk Management activities throughout all phases of development and assurance the identified risks have been reduced as far as possible
- Ensure that requirements are appropriately defined and tested and that the stress-conditions appropriately challenge the design to insure regulatory and pharma-partner needs are satisfied by the assigned subsystems
- Guide various process and product development activities through sample-size determination, distribution identification and data analysis; and other means such as the selection, support and appraisal of inspection plans and process controls
- Provide analysis and evaluations to support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action program
- Incorporate assessments of operational performance, product quality and the effectiveness of corrective actions into the risk-management documentation for the platform
- Proactively communicate project risks and status to management and external partners as needed
- Manage other job functions and duties; and provide for other product development projects, teams and activities as required
- Provides project status to leadership
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What This Job Offers
Job Type
Full-time
Career Level
Senior
