Manufacturing Process Engineer II

Manufacturing Process Engineer II

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio includes diagnostics, medical devices, nutritionals, and branded generic medicines.

Location:

Scarborough, ME – Infectious Disease Business.

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.

• Develop processes based on product specifications and considering process and test method capabilities.
• Evaluate process and design alternatives based on Design for Manufacturability (DFM) principles.
• Use problem solving and statistical tools and make sound design recommendations.
• Manage program compliance with quality requirements such as Design Control and Process Validation.
• Identify work environment issues including OSHA regulations.
• Support company initiatives identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Conduct tests, collect and form data, and assist in analysis of engineering studies (DOEs).
• Assist in startup of new equipment and execution of validation protocols.
• Participate in technical design reviews for process equipment and product design and requirements documents.
• Support the quality system, including supporting quality incidents and CAPA investigations and actions.
• Analyze raw material specifications to ensure appropriate features and limits are in place.
• Evaluate company-initiated raw material changes and coordinate appropriate testing and validation.
• Reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provide detailed plans for improvement.
• Create and revise manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documents to ensure compliant, efficient, and safe processes.
• Conduct preventive maintenance audits and ensure compliance with SOPs, ISO, FDA, and cGMP requirements.
• Research engineering solutions to a diverse set of production and development challenges.
• Comply with U.S. Food and Drug Administration regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

• Multitasking: demonstrate the ability to handle multiple tasks simultaneously.
• Self‑motivation: proactive and self‑driven, seeks learning opportunities and maintains high productivity with minimal supervision.
• Verbal and written communication: effectively convey ideas in both individual and group settings.
• Analytical thinking/problem solving: dissect situations into smaller components and trace implications methodically.
• Teamwork and collaboration: work harmoniously with others and align personal goals with the team.

• Technical aptitude: interpret a variety of technical instructions in mechanical or diagram form.
• Mechanical aptitude: experience working with concepts such as ANSI/AQL, probability, and statistics.
• Financial fluency: understand and use financial concepts related to production, including cost of goods sold (COGS) and profitability analysis.
• Data analytics: experience with data analytics, data sources, compiling, statistical analysis, and sampling plans.
• CAD: experience in computer‑aided design and manufacturing software.

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

• Experience with cGMP and ISO 13485 regulations and practices.
• Experience with statistical analysis software such as Minitab or JMP.

• Career development opportunities.
• Health coverage under Abbott Health Investment Plan (HIP) PPO medical plan.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement and student debt programs.

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

Abbott is an Equal Opportunity Employer, committed to employee diversity.