Engineer II, 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, sponsors Risk Management activities, and ensures requirements are appropriately defined and tested to meet regulatory and partner needs. The role involves guiding process and product development activities, providing analysis for investigations and corrective actions, and incorporating assessments of operational performance into risk management documentation. The engineer will proactively communicate project risks and status, manage other job functions, and provide project status to leadership.
Requirements
- Bachelor’s Degree in Engineering discipline
- A minimum of 2 years of device/combo product design and development experience, working in a highly regulated environment, quality, manufacturing, or engineering
- Basic 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
- Competent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab)
- Strong time management skills
- Ability to apply competency in difficult situations
- Ability to follow defined procedures and proactively diagnose
- Ability to collaborate and maintain cooperative work relationships with others
- Ability to adapt to change and handle unexpected situations, Requires occasional guidance
- Ability to stay focused on tasks, organize, compare, and interpret data and assess problems with little guidance
- Shows inquisitiveness about how situations are evolving and identifies how to adapt early to changing situations
Nice To Haves
- Master’s Degree considered as an additional 2 years of experience
- ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certifications
- Quality Engineering Experience
- Comfortability in speaking with external partners regarding business need
- Work to acquire and develop new skills
- Engages colleagues with the Enable Values in mind
- Ability to maintain a positive attitude, show empathy for others, and always do the right thing
- Ability to have a positive impact on others in support of company goals and a healthy work environment
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
Entry Level
