Careers with InCube

Purpose of the job:

Design and develop automated test systems used in manufacturing of medical device products.

Major Duties and Responsibilities

• Design, develop, and test software applications and integrate turnkey systems for automated test, data acquisition, and control using LabVIEW and National Instruments and custom-designed hardware. Applications involve various technologies including electronic signal conditioning, PXI/PCI and instrument control; FPGA, real-time, and embedded systems; SQL database, and motion control.
• Write and manage test system requirement specifications and software design documents according to design control and company’s standard operating procedures.
• Implement software using configuration management, diagnose problems with electronic systems, participate in formal and informal code and design reviews, and ensure that engineering safety standards are met for all projects.
• Develop test plans and test procedures to complete Verification and Validation requirements before deploying ATE test systems for manufacturing uses.
• Work with ATE manager on development schedules and project plans for tracking ATE development projects and contribute to the development of organizational goals.

Education and/or Job Experience

• BS degree majoring in EE, Biomedical Engineering, or Computer Science.

Skills and Specifications

• Ability to design complex real-time control ATE test systems containing hardware electronics and software applications based on manufacturing test requirements to a high level of quality.
• Strong understanding and experience of developing software architecture, systems and software engineering process for generation of requirements, design documents, configuration control, and preparation of test plans and user documentation.
• Advanced knowledge of, or certification in, LabVIEW development by National Instruments.
• Advanced knowledge of and experience with real-time controls hardware, data acquisition systems.
• Hands-on programming experience with National Instrument programming tools like LabVIEW.
• Basic understanding of electrical engineering bench top equipment like digital oscilloscopes, power supply, and data acquisition modules.
• Experience working effectively in a dynamic multidisciplinary environment, which includes working with scientists, engineers, technicians, and designers.
• Proficient verbal and written communication skills necessary to effectively collaborate in a team environment and present and explain technical information.
• Experience in a regulated industry is desired (medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and IEC 60601 is highly preferred). Medical device verification and validation experience is also desired.
• Strong problem-solving skills, work ethic, and drive to succeed.

Purpose of the Job:  

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Major Duties and Responsibilities

• Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
• Support quality assurance activities, including, but not limited to: IQC, in-process and finished product testing and product release, Risk Management (FMEA, hazard analysis), internal and external audits and NCMRs and CAPAs
• Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
• Lead the resolution of quality issues related to non-conformance reports and CAPAs
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
• Provide QE support to production, purchasing and engineering
• Support/lead test method validation activities
• Conduct and support the development and validation of appropriate test methods for product and process performance
• Develop and initiate sampling procedures and statistical process control methods
• Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
• Manage the Non-conforming Materials Review (NCMR) in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material/ product incidences
• Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
• Address systemic quality issues with suppliers or internal groups
• Oversee calibration and preventive maintenance program
• Oversee receiving inspection. Establish and implement systems to ensure timely quality inspections for incoming materials, components or finished goods products. Identify and report nonconforming material
• Perform/manage review of lot history records and disposition of product (subassembly and finished goods)
• Work with engineering to develop adequate inspection criteria
• Perform statistical analysis such as capability, gage R&R, and statistical process control
• Evaluate product changes for qualification and validation requirements and assist in change implementations
• The position has supervisory responsibilities for a team of 5-8 direct reports
• Other duties/ activities may be necessary to support departmental or company goals

Education and/or Job Experience

• A Minimum of 10 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is required
• BS degree in Engineering is required
• A Minimum of 3 years’ experience supervising employees
• Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
• Experience with non-conformances, CAPA, and Risk Management is required
• Experience in performing test method validation and Gage R&Rs
• Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
• CQE, CQA preferred

Skills and Specifications

• Ability to motivate and influence people
• Organizing, planning, and problem-solving skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
• Ability to create and provide training
• Good statistical and numerical ability