Manufacturing Engineer II in Scarborough, ME at APEX Systems

Date Posted: 2/13/2020

Job Snapshot

  • Employee Type:
    Contractor
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    2/13/2020

Job Description

Job #:  1026287
Excellent opportunity for a Manufacturing Engineer in Scarborough, ME who wants to work in the medical device / biotechnology industry. 
For immediate response, please send resumes to ccrimmins@apexsystems.com
Summary
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, and 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.
  • Minimum three years engineering experience in a manufacturing environment
  • Experience working in a GMP, FDA, ISO and USDA regulated environment preferred
  • Process Engineering, Validation, JMP Analytical, Minitab, Solidworks, Mechanical

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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.