Development Quality Engineer I

Key Responsibilities

• Ensure requirements for Device/Combination Products through the execution of Abbott standard operating procedure and Product Lifecycle Management.
• Utilize technologies to collect, clean, analyze, predict, and effectively communicate information.
• Examine and interpret relevant data to quickly develop an analysis plan that will answer key business questions and create value for the organization.
• Analyze data, draw insights, and present results in a cohesive, intuitive, and simplistic manner to site and executive management.
• Work with cross-functional teams to devise test methodologies to ensure validity of the data models being presented.
• Work closely with the business to understand the domain and iteratively refine analyses.
• Identify opportunities to improve the efficiency and effectiveness of the systems and process being examined (process improvement/reengineering projects).
• Identify and implement continuous improvement opportunities throughout the data lifecycle.
• Act as Subject Matter Expert in cross-functional team meetings as well as internal and external audits.
• Ensure compliance with associated regulations, standards, and site procedures.
• May demonstrate basic project management skills by acting as a project lead on small, well-defined projects.

Requirements & Tech Stack

• Particularly skilled in quantitative analysis and data management.
• Understanding of machine learning algorithms and advanced statistics such as: regression, time-series forecasting, clustering, decision trees, exploratory data analysis methodology, simulation, scenario analysis, modeling, optimization.
• Demonstrated personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc., to develop presentation materials.
• Ability to work with engineers, technical specialists, vendors, and customers to achieve assigned goals.
• Ability to coordinate multiple assignments simultaneously and effectively.
• 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.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel.
• Drive to learn applicable regulations and standards such as FDA, QSR and ISO regulations.
• Demonstrated written, oral and interpersonal skills.
• Strong analytical skills, problem solving techniques and statistical application experience.

Qualifications

• Bachelors Degree (± 16 years) in Engineering, Life Sciences, or Physical Sciences OR an equivalent combination of education and work experience.
• Minimum 1 year of related work experience.
• 1-2 years experience in pacing industry.
• Quality experience desired.
• 0-2 years of experience in Quality Assurance, Technical Quality, or equivalent.
• Some knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques.

Preferred Qualifications

• Bachelors Degree focused in Data Analytics, Data Science or similar discipline including Engineering, Mathematics, Computer science, Statistics or Physics preferred.
• 1-2 years’ of related work experience with a good understanding of specified functional area.
• Experience working in life sciences or healthcare industry preferred.
• Working experience with database applications including programming experience (e.g. SQL, Python, R, Java, Scala, C++ in Linux/Unix and/or equivalent).
• Experience implementing process improvements and efficiencies.
• Strong excel skills.
• Excellent verbal and written communications skills to explain data analysis findings.
• Self-starter who can plan their own work to meet deadlines.
• Strong interpersonal skills, be self-motivated, have a strong desire to learn, and be adaptable to a fast paced, ever-changing environment.