Senior Manufacturing Process Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

• Career development with an international company where you can build the career you dream of.
• Employees can qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit – an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company recognized as one of the best large companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry‑leading technologies to support diagnostic testing that provides important information for treatment and management of diseases and other conditions.

The position of Senior Manufacturing Process Engineer is within our Infectious Disease Business Unit located in Scarborough, Maine. This role will be responsible for all Manufacturing Equipment and equipment quality/cost savings initiatives, improving efficiency through material and process improvement, reducing material processing costs, and participating in new product design.

• Owns and is responsible for processes based on product specifications and in consideration to process and test method capabilities.
• Evalues and drives process and design alternatives based on Design for Manufacturability (DFM) principles.
• Solves highly technical and complex problems using problem solving and statistical tools and makes sound design recommendations.
• Manages program compliance with Quality requirements (i.e., Design Control, Process validation, etc.).
• Maintains knowledge of new developments in manufacturing and design technologies.
• Can identify and propose and own solutions for work environment issues (i.e., OSHA regulations, etc.).
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Designs and leads tests, collects, analyzes and forms data, supporting engineering studies (DOE).
• Engages in startup of new equipment, defining and executing validation protocols based on requirements.
• Communicates effectively and participates on cross‑functional development teams.
• Leads in technical design reviews for process equipment and product design and requirements documents.
• Responsible for utilizing and maintaining the effectiveness of the quality system, including supporting Quality Incidents and CAPA investigations and actions.
• Analyzes raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process.
• Evaluates and owns change actions associated with company initiated raw material changes and coordinates appropriate testing and validation as required.
• Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement.
• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe processes.
• Conducts operational procedure audits to ensure compliance with SOPs, ISO, FDA and cGMP requirements.
• Researches engineering solutions to…