Senior Manufacturing Process Engineer

Abbott • Scarborough, ME

17h • $78,000 - $156,000 • 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 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. This job description will be reviewed periodically and is subject to change by management.

Requirements

• 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.

Nice To Haves

• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
• Proficient with cGMP and ISO 13485 regulations and practices.
• Proficient with statistical analysis software. (Minitab or JMP preferred)

Responsibilities

• Owns and is responsible for processes based on product specifications and in consideration to process and test method capabilities
• Evaluates 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 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 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 formats data, supporting engineering studies (DOEs).
• Engages in startup of new equipment, defining and executing validation protocols based on requirements.
• Communicates effectively and participate 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 insure compliant, efficient and safe processes.
• Conducts operational procedure audits to ensure compliance with SOPs, ISO, FDA and cGMP requirements.
• Researches engineering 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.

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: Senior