JOB DESCRIPTION:Manufacturing Process Engineer IIThe OpportunityAbbott 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.
What You'll Work On- 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.
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
- Self-Motivated: Demonstrates a proactive attitude, consistently drives personal and team goals, seeks avenues of learning and growth, and maintains high productivity with minimal external supervision.
- 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.
- Teamwork and Collaboration: Demonstrates professional cooperation by working together harmoniously with others, being an integral part of a team, respecting others' contributions, and aligning personal goals with those of the team.
Engineering Competencies:- Technical Aptitude: Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Mathematical Aptitiude: Experience in working with mathematical concepts such as ANSI/AQL, probability, and statistics.
- Financial Fluency: Exposure to understanding and effectively using various financial skills related to production, including Cost of Goods Sold (COGS), Profitability Analysis, Pricing Strategy, and Inventory Management.
- Data Analytics: Experience in Data Analytics, understanding of data sources, compiling, statistical analysis, and sampling plans.
- CAD: Experience in computer-aided design (CAD) and manufacturing software for designing system layouts.
Required Qualifications- 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.
PREFERRED QUALIFICATIONS:- Experience with cGMP and ISO 13485 regulations and practices.
- Experience with statistical analysis software. (Minitab or JMP preferred)
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Divisional InformationDiagnosticsWe're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Manufacturing
DIVISION:ID Infectious Disease
LOCATION:United States > Scarborough : 10 Southgate Rd
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment, Work in noisy environment
