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Manufacturing Engineer I in Scarborough, ME at APEX Systems

Date Posted: 5/13/2019

Job Snapshot

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Job Description

Job #:  949143
Our client in the Biotechnology/Medical Device Industry is looking for two Manufacturing Engineers in the Scarborough, ME area. 
Please email your resume to for immediate response. 
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.
Essential Duties and Responsibilities
  • 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. 
  • Evaluation of machine logic, electromechanical systems and process controls to troubleshoot equipment.
  • AutoCAD or Solidworks drafting and design capability.
  • 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
  • Actively 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. 

Measures of Performance:
  • Appropriate process and equipment definition.
  • Quality of communication and documentation
  • Time management and project metrics.
  • Implementation of core engineering principles.
  • Mentoring of technicians and operators

Education and/or Experience  
-Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
-One to three years engineering experience in a manufacturing environment
-Experience working in a GMP, FDA, ISO and USDA regulated environment preferred
Language Skills  
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills  
Ability to work with mathematical concepts such as ANSI/AQL, probability and statistics.
Reasoning Ability  
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills  
To perform this job successfully, an individual should have knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.  Familiarity with statistical analysis software (Minitab) is preferred.
Other Skills and Abilities  
  • Must be able to work on problems of diverse scope where analysis of the problem requires evaluation of obscure or unknown data
  • Must be able to use precision measuring equipment, hand and power tools
  • Must be able to meet deadlines while working on multiple projects
  • Familiarity with cGMP and ISO 13485 regulations and practices is desired
  • Familiarity with a variety of material testing and measuring methods

For Immediate Consideration please send your most up to date resume to '' with the subject line 'Manufacturing Engineer'.
EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.