Manufacturing Process Engineer II

Abbott • Scarborough, ME

2d • Onsite

About The Position

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 which provides important information for treatment and management of diseases and other conditions. The position of Manufacturing Process Engineer II is within our Infectious Disease Business located in Scarborough, ME. This role is 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.

Requirements

• Bachelor's degree (BS) in Engineering or equivalent combination of education and experience.
• 3+ years’ engineering experience in a manufacturing environment.
• Technical experience in mechanical, biomedical, industrial or chemical engineering.
• Experience in performing engineering calculations, controlled tests, statistical analyses.
• Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, etc.)
• Experience in change management principles and processes.

Nice To Haves

• Experience with cGMP and ISO 13485 regulations and practices.
• Experience with statistical analysis software. (Minitab or JMP preferred)

Responsibilities

• Develops processes based on product specifications and in consideration to process and test method capabilities
• Evaluates process and design alternatives based on Design for Manufacturability (DFM) principles.
• Uses problem solving and statistical tools and make sound design recommendations.
• Manages program compliance with Quality requirements (i.e. Design Control, Process validation etc.).
• Can identify 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.
• Conducts tests, collects and formats data, and assists in analysis of engineering studies (DOEs).
• Assists in start up of new equipment and execution of validation protocols.
• Participates 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 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 insure compliant, efficient, and safe processes.
• Conducts preventative maintenance audits and compliance with SOPs, ISO, FDA and cGMP requirements.
• Researches engineering solutions to a diverse set of challenges in production and development.
• 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.

Benefits

• Employees can qualify for free medical coverage in our 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees