Abbott · 5 hours ago
Senior Manufacturing Process Engineer
Scarborough, ME
Full-time
Onsite
Mid, Senior Level
$78K/yr - $156K/yr
7+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Manufacturing Process Engineer will support manufacturing equipment and quality initiatives, improve efficiency through material and process improvements, and participate in new product design.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
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 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
Qualification
Required
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
Proficient with cGMP and ISO 13485 regulations and practices
Proficient with statistical analysis software. (Minitab or JMP preferred)
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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