Engineer II Process – Controls

Abbott Laboratories; New Jersey; On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott Laboratories in the United States is seeking an Engineer to develop and optimize manufacturing processes for medical devices. You will analyze product specifications, design for manufacturability, and ensure compliance with FDA and QMS requirements.

The role requires 2–4 years of manufacturing experience, strong technical communication, and the ability to work in a matrixed environment with cross-functional teams and vendors. Travel may be required.

Qualifications

• Bachelor's degree in engineering or technical field.
• 2–4 years of manufacturing experience; medical devices design/testing is required.
• Experience designing and testing manufacturing processes and design-for-manufacturability.
• Willingness to travel internationally.

Responsibilities

• Establish processes based on product specifications and quality requirements.
• Evaluate design and process alternatives using design-for-manufacturability principles.
• Ensure compliance with FDA regulations, QMS, EMS, and other regulatory requirements.
• Maintain knowledge of new manufacturing/design technologies and collaborate cross-functionally.

Skills

Manufacturing experience

Design for manufacturability

Technical communication

Education

Bachelor's Degree in Engineering

Tools

FDA regulations

Job description

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.

QUALIFICATIONS

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.

JOB FAMILY: Engineering DIVISION: CRM Cardiac Rhythm Management LOCATION: United States > Liberty : 253 Financial Blvd. ADDITIONAL LOCATIONS:

WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.