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Engineer, Manufacturing

Collins Consulting, Inc

Westbrook, ME

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
American National Standards Institute (ANSI), Analysis Skills, Business Development, CAD (Computer-Aided Design) Software, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cost Control, Current Good Manufacturing Practice (cGMP), Data Analysis, Database Management Software/Systems (DBMS), Electromechanical Systems, Engineering, Engineering Management, Equipment Specification, Experiment Design, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Infectious Diseases, Internet Application, Machine Tool, Maintenance Services, Manufacturing, Manufacturing Engineering, Manufacturing Requirements, Manufacturing Software, Manufacturing/Industrial Processes, Materials Testing, Mathematics, Mentoring, Microsoft Excel, Microsoft Word, Minitab, Problem Solving Skills, Process Control Engineering, Process Development, Product Development, Product Support, Project Management Software, Project/Program Management, Quality Assurance Methodology, Quality Management, Regulations, Risk Analysis, Root Cause Analysis, Safety Compliance, Safety Process, Safety Standards, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Statistics, Statistics Software, Team Lead/Manager, Team Player, Technical Writing, Testing, Training/Teaching, United States Department of Agriculture (USDA), Validation Plan, Willing to Travel
LOCATION
Westbrook, ME
POSTED
30+ days ago
This is an onsite position. The position of Manufacturing Engineer II is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will be responsible for supporting product development from concept through sustained manufacturing of FDA regulated products. Support of process development and equipment acquisition. Experience with manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP, quality and safety standards. If you seek a dynamic role where your contributions will pave the way in developing new products, systems, and processes, come work with us! This job description will be reviewed periodically and is subject to change by management. RESPONSIBILITIES: Responsible for process development, equipment specification, acquisition and implementation. Works to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent reoccurrence. Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment. Completes design of experiments, validation, completion of testing and analysis of data for continuous improvement activities. Presents data to equipment teams. Suggests and supports new methods or materials for continual improvement of quality and efficiency. Analyzes 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 ensure compliant, efficient and safe procedures Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary Participates in teams as necessary to ensure continual improvement, safety and compliance Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation. Manages engineering project teams and coordinates activities. Mentors junior engineers and maintenance technicians. Initiates and works to resolve Quality Incidents and CAPA. Ability to travel up to 25% of the time BASIC QUALIFICATIONS | EDUCATION: Bachelor's degree (BS) in engineering or equivalent combination of education and experience. Minimum three years engineering experience in a manufacturing environment Familiarity with a variety of material testing and measuring methods. Knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software. PREFERRED QUALIFICATIONS: Experience working in a GMP, FDA, ISO and USDA regulated environment. Familiarity with cGMP and ISO 13485 regulations and practices. Familiarity with statistical analysis software (Minitab). COMPETENCIES: Ability to work with mathematical concepts such as ANSI/AQL, probability and statistics.

About the Company

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Collins Consulting, Inc

Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs. We have an established history of serving clients nationwide in both the public and private industries. These clients range from Fortune 100 companies within the commercial arena to supporting contracts within federal agencies.

Collins Consulting is a certified Service-Disabled Veteran Owned Small Business and a SBA Small Business. We believe in servicing our country's veterans by supporting and nurturing opportunities to join their skillsets with clients who have the same principles. These certifications coupled with Top Secret facility clearance allow us to meet category and diversity goals.

Collins Consulting is agile, innovative, and an award winning advocate in providing total talent solutions to serve your business needs. Whether you are a professional who is looking for a new career or an organization in need of experienced talent, we have the resources to help you.

COMPANY SIZE
10 to 19 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
http://www.colcon.com