Engineer II Process – Controls

Abbott; Liberty (SC); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott is a global healthcare leader seeking an engineer to develop design specifications and performance requirements for medical devices. You will assess manufacturing processes, ensure design for manufacturability, and maintain compliance with regulatory standards.

Role requires 2+ years in manufacturing with device design/testing experience, travel ability, and collaboration across teams in a matrixed environment.

Qualifications

• Bachelor's degree in Engineering or technical field.
• 2+ years manufacturing experience; 2–4 years preferred.
• Experience designing and testing medical devices is required.

Responsibilities

• Establishes processes based on product specifications.
• Evaluates process and design alternatives based on design for manufacturability.
• Understands cost of goods sold.
• Manages program compliance with Quality Control requirements (e.g., Design Control, Process validation).
• Understands IP issues related to developed processes.
• Keeps knowledge up to date with advances in manufacturing and design technologies.
• Complies with FDA regulations and other regulatory requirements; supports QMS and EMS.

Skills

Design for manufacturability

Manufacturing analysis

Medical devices

Education

Bachelor's degree in Engineering or technical field

Tools

Quality Management System (QMS)

Design Controls

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 115,000 colleagues serve people in more than 160 countries.

MAIN PURPOSE OF ROLE

• Performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations.

Main Responsibilities

• Establishes processes based on product specifications.
• Evaluates process and design alternatives based on “design for manufacturability” principles.
• Understands principles of “Cost of Goods Sold”.
• Manages program compliance with “Quality Control” requirements (i.e. Design Control, Process validation etc.).
• Understands IP issues relative to processes being developed.
• Maintains knowledge of new developments in manufacturing and design technologies.
• Understand work environment issues (i.e. OSHA regulations, etc.).
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education

• Bachelors Degree (± 16 years)
• Engineering or Technical Field

Experience/Background

• Minimum 2 years
• 2 – 4 years manufacturing experience. Experience designing and testing medical devices required. Experience developing manufacturing processes and technologies and designing for manufacturability required.
• Experience working in a broader enterprise/cross-division business unit model preferred. 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, including internationally.

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.