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Manufacturing Engineer in North Haven, CT at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

Job Description

Seeking a Manufacturing Engineer for a medical device company in North Haven, CT. This opening is for a 1-year project. Ideal candidates have a degree in Mechanical Engineering and experience working in a highly regulated environment. Please, no industrial engineers at this time.

Primary Responsibilities:

  • Provides daily direction to manufacturing and maintenance personnel to set up, trouble shoot and repair automated suture manufacturing equipment. 
  • Provides expertise in specification, procurement, build, documentation, validation and personnel training on automated manufacturing equipment. 
  • Teams with procurement engineering to specify automated equipment specifications, review equipment design and builds at outside suppliers and determine machine acceptance and potential changes at equipment FAT’s (Factory Acceptance Tests). 
  • Provides documentation and education of equipment operation to engineering, manufacturing and maintenance personnel. 
  • Maintains control of system software’s, control logic program files, mechanical and electrical schematics, drawings and bills of materials and revision histories. 
  • Assures back up of all electronic PLC and PC driven systems program media and revisions are up to date. 
  • Reviews manufacturing equipment and process for improvement potentials using statistical data and analysis of OEE (Overall Equipment Efficiency) reports. 
  • Reviews equipment improvement and replacement requirements and authors CER’s (Capital Equipment Requisitions) for managers review and submission to obtain project funding, solidify project start and finish dates and document internal or outside contractor resources. 
  • Teams with manufacturing and quality personnel on a daily basis to review, disposition production defects (QN’s – quality notifications) and provide potential process or equipment corrective actions to assure production schedules are met. 
  • Review product field returns with Quality Assurance personnel to determine root cause of potential manufacturing defects and provide process corrective actions if a defect trend analysis documents an unstable process. 

Department Specific Functions:

  • Engineer will be assigned to Operational Excellence teams for support as required. 
  • Engineer will be assigned to PDP (Product Development Process) teams as required. 
  • Engineering driven change notices, BOM creation, SPAC system.

Organizational Scope:

  • Position reports to Engineering Manager or delegated Department Sr. OR Principle Engineer. 
  • Will maintain excellent communications with Manufacturing, Quality, Maintenance, Safety and Metrology departments on an as needed basis. 

Educational Requirements: 

  • Associate's or Bachelor's Degree in Mechanical Engineering or equivalent experience
  • 1-3 years of experience for an Associate's or Bachelor's
  • 0-2 for Master's Degree

Desired Skills:

  • Process Validation (IQ, OQ, PQ)
  • Six Sigma Training/Certification
  • Project Management Experience


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.