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Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
- 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
Preferred:
- ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certifications
- Quality Engineering Experience
Skills & Competencies:
- 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
Physical Requirements:
- Must be able to gown and work within a clean room and/or lab environment
- Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs.
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
- Position requires being physically present on the premises during regular company hours or as approved by management
Responsibilites:
- 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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