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Senior Manufacturing Automation Engineer

Iconma

Westbrook, ME

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JOB DETAILS
SALARY
$46.37–$48.69 Per Hour
SKILLS
Agile PDM, American National Standards Institute (ANSI), Analysis Skills, Automation, Automation Engineering, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), CNC Lathe, Change Management, Computer Skills, Continuous Improvement, Corporate Policies, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Documentation, Educational Technology, Electromechanics, Engineering, Equipment Specification, Ergonomics, Establish Priorities, Experiment Design, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), Health Plan, Healthcare, ISO (International Organization for Standardization), Identify Issues, Lead Generation, Lean Six Sigma, Machine Tool, Maintenance Services, Manufacturing, Manufacturing Automation, Manufacturing Design, Manufacturing Equipment, Manufacturing Requirements, Manufacturing Software, Manufacturing Systems, Manufacturing/Industrial Processes, Materials Testing, Mathematics, Mentoring, Microsoft Excel, Microsoft PowerPoint, Microsoft Product Family, Multitasking, Operations Processes, Plan Meetings, Policy Development, Power BI, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Control Engineering, Process Development, Process Improvement, Process Validation, Project/Program Coordination, Quality Assurance Methodology, Quality Management, Regulations, Regulatory Requirements, Risk Analysis, Root Cause Analysis, Safety Compliance, Safety Process, Six Sigma DMAIC, Software Design, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Statistics, Statistics Software, Strategic Planning, Team Lead/Manager, Team Player, Technical Writing, Testing, Training/Teaching, United States Department of Agriculture (USDA), Validation Plan, Welding
LOCATION
Westbrook, ME
POSTED
1 day ago
Our Client, a Medical Devise and Healthcare company, is looking for a Senior Manufacturing Automation Engineer for their Westbrook, ME location.
 
Responsibilities:
  • Carries out duties in compliance with established business policies and procedures.
  • Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that 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 related tasks as requested.
  • Responsible for equipment specification, acquisition, and implementation.
  • Leads automation equipment upgrade efforts related to safety, obsolescence, and continuous improvement initiatives.
  • Evaluates machine logic, electromechanical and process controls to troubleshoot equipment and drives to resolution.
  • Leads teams to identify root cause of manufacturing failures using structured problem solving.
  • Applies root cause fixes to prevent recurrence.
  • Conducts failure modes and effects analysis and evaluates manufacturing equipment risk.
  • Completes complex projects based on comprehensive knowledge of manufacturing equipment and processes.
  • Leads design of experiments, validation, completion of testing and analysis of data.
  • Presents data to cross functional teams.
  • Drives implementation of 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.
  • Leads other engineers and technicians in developing solutions and improvements in materials, equipment, and process as necessary in addition to ensuring continual improvement, safety, and compliance.
  • Manages cross functional project teams and coordinate activities.
  • Provides training and process expertise for product processing in specific areas such as process development, tooling development, documentation, cleaning protocol, process characterization and validation.
  • Initiates and leads to resolution of Quality Incidents and CAPA.
  • Participates in teams as necessary and mentors junior engineers and maintenance technicians to ensure continual improvement, safety, and compliance.
  • Considers safety, ergonomic, maintenance, and operator impact on manufacturing design.
  • Interacts with the local Project Management Office on milestones and project status updates.
  • Participates in site strategy meetings and planning.
  • Leads change through Agile PDM.
  • 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.
 
Requirements:
  • Basic qualifications | education:
  • Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
  • 7+ years engineering experience in a manufacturing environment
  • Experience in the application of lean six sigma principles and the DMAIC approach or a similar structured problem-solving system.
  • Proficiency in change management principles and processes.
  • Preferred qualifications:
  • Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
  • Experience working in a GMP, FDA, ISO and USDA regulated environment.
  • Experience in cGMP and ISO 13485 regulations and practices.
  • Experience in statistical analysis software.
  • Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, etc.)
  • General competencies:
  • Innovative Thinking: Independently generates new, creative, and sometimes unconventional ideas to problem solve or improve current processes and structures while seeking feedback from managers and coworkers.
  • 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, 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.
  • 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.
  • Technical competencies:
  • Fabrication Principles: Proficiency in fabrication principles including CNC, lathe, milling, welding, and bolted connections.
  • Mathematical Aptitude: Proficiency in mathematical concepts such as ANSI/AQL, probability, and statistics.
  • Technical Aptitude: Proficiency in the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • CAD: Experience in computer-aided design (CAD) and manufacturing software for designing system layouts.
  • Materials Testing: Proficient in a variety of testing and measuring methods relating to the process of evaluating the properties and performance of materials used in manufacturing.
 
Why Should You Apply?  
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.
 

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/