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 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.

The position ofSeniorManufacturing Process Engineer is within our Infectious Disease Business Unit locatedin Scarborough,Maine.This role willbe responsible forallManufacturing Equipment and equipment quality/cost savings initiatives, improving efficiency through material and process improvement, reducing material processing costs, andparticipatingin new product design.

This job description will be reviewed periodically and is subject to change by management.

What You?ll Work On

• Owns and is responsible for processesbased on product specifications and in consideration to process and test method capabilities
• Evaluatesand drivesprocess and design alternatives based onDesign forManufacturability(DFM)principles.
• Solveshighly technical and complexproblems using problem solving and statistical tools and make 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 forwork environment issues (i.e. OSHA regulations, etc.).
• Supportsall Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Designs andleadstests, collectsanalyzes andformatsdata,supportingengineering studies (DOEs).
• Engages instartup of new equipment, definingand executingvalidation protocolsbased on requirements.
• Communicateseffectively and participate on cross functional development teams.
• Leadsin technical design reviews for process equipment and product design and requirements documents.
• Responsible for utilizing and maintaining the effectiveness of the quality system, including supportingQuality Incidents and CAPA investigations and actions.
• Analyzesraw material specifications to ensure appropriatefeatures and limits are in place to support company manufacturing process.
• Evaluatesand owns change actions associated withcompany initiated raw material changes and coordinates appropriate testing and validation as required.
• Works to reduce costs in all areas of manufacturing byanalyzingcurrent 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.
• Conductsoperational procedureauditsto ensurecompliance with SOPs, ISO, FDA and cGMP requirements.
• Researchesengineering solutions to a diverse set of challenges in production and development.
• Mentors junior engineers and maintenance technicians to ensure continual improvement, safety, and compliance.
• Leads change through Agile PDM.
• 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.
• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company?s policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Support department by performing related tasks as requested.

COMPETENCIES:

General Competencies:

• Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities
• Verbal and Written Communication: Effectively conveys ideas in both individual and group settings, adapting style and methods to suit the audience?s needs, both verbally and in writing.
• Analytical Thinking/Problem Solving: The ability to dissect a situation, issue, or problem into smaller components or trace its implications methodically.
• Strategic Planning: Develops both short- and long-term plans that are comprehensive, innovative, realistic, and effective in achieving goals. Ensures these plans are seamlessly integrated across various departments, fostering collaboration and coherence in the planning process.
• Vendor Management: Overseeing and coordinating relationships with suppliers and service providers to ensure that an organization receives high-quality goods and services.

Technical Competencies:

• Technical Aptitude:Proficiency in the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.?
• Mathematical Aptitude:Proficiency in the ability to work with mathematical concepts such as ANSI/AQL, probability, and statistics.?
• Financial Fluency:Experiencein understandingand effectively usingvarious financial skills related to production, including Cost of Goods Sold (COGS), Profitability Analysis, Pricing Strategy, and Inventory Management.?
• Data Analytics:Proficient in data analytics, understandingof data sources, compiling, statistical analysis, and sampling plans.?
• CAD:Proficient in computer-aided design (CAD) and manufacturing software for designing system layouts.
• QMS: Experienced in Quality Management Systems and Change Control.

Required Qualifications

• Bachelor\'s degree (BS) in Engineering or equivalent combination of education and experience.
• 7+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 with change management principles and practices.

PREFERRED QUALIFICATIONS:

• Prior experience working in a companyoperatingunder ISO, FDA, or similar quality systems or regulations.
• Proficientwith cGMP and ISO 13485 regulations and practices.
• Proficientwith statistical analysis software.(Minitab or JMP preferred)

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The base pay for this position is $78,000.00 ? $156,000.00. In specific locations, the pay range may vary from the range posted.