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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