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Senior Manufacturing Process Engineer

Location : Monroe NY US 10950
Job Type : Temp/Contract to Direct
Reference Code : 20948-BZ1
Compensation : open - 45-55/h
Start Date : 03/15/2022
Hours : Full Time
Required Years of Experience : 7
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract to direct position for a Senior Process Engineer to ensure the design transfer process is completed successfully for medical device manufacturing.

  • Utilize process and manufacturing engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.

  • Provide engineering support for new product and process introductions.

  • Ensure that all activities are completed and documented in accordance with SOPs.

  • Ensure quality of process and product as defined in the appropriate operation and product specifications.

  • Assist in the selection of equipment based on analysis of specifications, reliability, and regulatory requirements.

  • Support capital acquisition activity from specifying equipment, installation, and process validations.

  • Analyze equipment to establish operating data, conduct Design of Experiments (DOEs) and result analysis.

  • Lead and participate in process review meetings.

  • Define manufacturing assembly and inspection tools / fixtures as needed to support product / process development activities.

  • Lead in process failure mode and effect analysis (PFMEA), quality control plans, SOPs, and production part approval process (PPAP) generation associated with product transfers and launches.

  • Complete process capability studies for in-process inspection(s) and generate subsequent inspection documentation.

  • Conduct process validation, including review and approval of validation documentation, and MSA studies for new products / processes.

  • Drive and execute effective communication with all stakeholders to enable project success.

  • Work in a hands-on manner at the manufacturing site to support the implementation of new processes.

  • Provide training for manufacturing team members.

Required Qualifications :

  • BS Engineering required, Mechanical or Process Engineering preferred.

  • Minimum 7 years experience with Manufacturing Process Engineering for Medical Devices is required.

  • Experience with Writing and Executing Validations is required.

  • Ability to read and interpret complex engineering drawings and understand geometrical dimensioning & tolerancing.

  • Lean Six Sigma Green Belt Certification or above is preferred.

Contact: Bill Zukowsky

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