Senior Manufacturing Process Engineer
Abbott
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 114,000 colleagues serve people in more than 160 countries.
Senior Manufacturing Process Engineer
Working at Abbott
At Abbott, you can do work that matters, 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 international 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 education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that 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 information for treatment and management of diseases and other conditions.
The position of Senior Manufacturing Process Engineer is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will support 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
- 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 anaylzes and formats data, supporting engineering studies (DOEs).
- Engages in start up of new equipment, defining and executiing 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 assocaited 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.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Mentors junior engineers and maintenance technicians to ensure continual improvement, safety, and compliance.
- Leads change through Agile PDM.
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:
- Proficient with cGMP and ISO 13485 regulations and practices.
- Proficient with statistical analysis software. (Minitab or JMP preferred)
Learn 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. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
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.