Abbott is a global healthcare leader th helps people live more fully 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.
Senior Manufacturing Process Engineer
Working Abbott
At Abbott, you can do work th mters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
Career development with an internional company where you can grow the career you dream of.
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 educion benefit - an affordable and convenient ph to getting a bachelor’s degree.
A company recognized as a gre place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company th is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
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 informion for trement and management of diseases and other conditions.
The position of Senior Manufacturing Process Engineer is within our Infectious Disease Business Unit loced in Scarborough, Maine. This role will be responsible for all Manufacturing Equipment and equipment quality/cost savings initiives, improving efficiency through merial and process improvement, reducing merial processing costs, and participing in new product design.
This job description will be reviewed periodically and is subject to change by management.
Wh You’ll Work On
- Owns and is responsible for processes based on product specificions and in considerion to process and test method capabilities
- Evalues and drives process and design alternives based on Design for Manufacturability (DFM) principles.
- Solves highly technical and complex problems using problem solving and stistical tools and make sound design recommendions.
- Manages program compliance with Quality requirements (i.e. Design Control, Process validion 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 regulions, etc.).
- Supports all Company initiives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulory requirements.
- Designs and leads tests, collects analyzes and forms da, supporting engineering studies (DOEs).
- Engages in startup of new equipment, defining and executing validion protocols based on requirements.
- Communices effectively and participe 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 investigions and actions.
- Analyzes raw merial specificions to ensure approprie feures and limits are in place to support company manufacturing process.
- Evalues and owns change actions associed with company initied raw merial changes and coordines approprie testing and validion as required.
- Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement.
- Crees and revises manufacturing documents, specificions, standard opering procedures (SOPs), safety instructions, validion protocols, risk assessments, and procedures and other technical documents to insure compliant, efficient and safe processes.
- Conducts operional 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 Administrion (FDA) regulions, other regulory requirements, Company policies, opering procedures, processes, and task assignments. Maintains positive and cooperive communicions and collaborion with all levels of employees, customers, contractors, and vendors.
- Carries out duties in compliance with established business policies and procedures.
- Demonstres commitment to the development, implemention and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associes th 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 reled tasks as requested.
COMPETENCIES:
General Competencies:
- Multitasking: Demonstres the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities
- Verbal and Written Communicion: 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 situion, issue, or problem into smaller components or trace its implicions methodically.
- Stregic Planning: Develops both short- and long-term plans th are comprehensive, innovive, realistic, and effective in achieving goals. Ensures these plans are seamlessly integred across various departments, fostering collaborion and coherence in the planning process.
- Vendor Management: Overseeing and coordining relionships with suppliers and service providers to ensure th an organizion receives high-quality goods and services.
Technical Competencies:
- Technical Aptitude: Proficiency in the ability to interpret an extensive variety of technical instructions in mhemical or diagram form and deal with several abstract and concrete variables.
- Mhemical Aptitude: Proficiency in the ability to work with mhemical concepts such as ANSI/AQL, probability, and stistics.
- Financial Fluency: Experience in understanding and effectively using various financial skills reled to production, including Cost of Goods Sold (COGS), Profitability Analysis, Pricing Stregy, and Inventory Management.
- Da Analytics: Proficient in da analytics, understanding of da sources, compiling, stistical 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 Qualificions
- Bachelor's degree (BS) in Engineering or equivalent combinion of educion and experience.
- 7+ years engineering experience in a manufacturing environment.
- Technical experience in mechanical, biomedical, industrial or chemical engineering.
- Experience in performing engineering calculions, controlled tests, stistical 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 company opering under ISO, FDA, or similar quality systems or regulions.
- Proficient with cGMP and ISO 13485 regulions and practices.
- Proficient with stistical analysis software. (Minitab or JMP preferred)
Apply Now
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Follow your career aspirions to Abbott for diverse opportunities with a company th can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is $78,000.00 – $156,000.00. In specific locions, the pay range may vary from the range posted.
