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)

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.

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.