Product Performance Engineer

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Description Summary - Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met

Job Description - We are seeking an experienced, high caliber Product Performance Engineer to lead returned device analysis and data request fulfillment to ensure quality complaint investigations and support of the complaint handling process. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Employees act on their strong desire to make a difference, partner with others and put ideas into action. Employees are engaged by a work culture that is team-oriented, fast paced and progressive.

Impact this role will have on Abbott:

• Execute and support on-time completion of returned device analysis, contributing to overall Department timeliness metrics
• Accountable for timely device analysis and investigation completion, coding of analysis findings, documenting analysis results and determining when additional testing by the Engineering Test Lab is in order
• Engage cross-functionally with Manufacturing, Research & Development, Design Quality and Clinical to support Post Market Surveillance activities
• Support and ensure investigations are assigned for Manufacturing Assessment as appropriate
• Support new file manager training and process improvement initiatives
• Lead internal CAPA investigations into PPG process nonconformances
• Additional duties may be identified by functional management based on the current project/business objectives.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments including Good Manufacturing Practices.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, as assigned.

Equipment:

Work with a variety of returned device lab equipment, small hand tools, test equipment and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier and a personal computer with standard office software.

Working Conditions:

Work environment varies from well lighted office/cubicle, low to moderate noise level, laboratory environment with laboratory equipment, benches and stools.

Physical Demands:
Activities require a significant amount of sitting in front of a computer monitor, standing in the laboratory while conducting product analysis and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment, lab equipment etc. Perform tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees. May require some lifting or moving of lab and office equipment etc.

Your experience(s), education and knowledge will further expand Abbott's marketplace success:

• Bachelor level degree in Biomedical Engineering, Bio-Engineering, Mechanical Engineering, or similar; advanced degree a plus
• 0-2 years' experience in a degree-related field
• Hands on experience using standard lab equipment
• Experience with product performance analysis, analysis of device failure modes, etc.
• Experience with quality systems and standards compliance
• Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel on occasion as needed (less than 5%)
• Ability to maintain regular and predictable attendance.

Your preferred qualifications and education:

• Understanding of implantable medical field
• Root cause analysis experience
• Familiarity with FDA/ ISO standards and regulations
• ASQ CE or other professional certifications
• Experience working in a broader enterprise/cross-division business unit model

JOB FAMILY:

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