Molding EngineerManufacturing Engineer
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Job Location:
Londonderry, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Londonderry NH
6 Months contract
For NH role a good title to look for is Molding Engineer / Molding Process Engineer. She would rather teach someone DFMEAs and PFMEAs and she does want them to have experience with suppliers but not to the level of the other candidates that are starting for her.
Her current SME got the experience at Milliporesigma they manufacture a lot of raw materials for devices so a raw materials manufacturer for a regulated industry background would also be considered.
Companies to look at
- Milliporesigma
- Thermo fisher
They need to be able to qualify the mold itself on the production floor. Could also be more of a manufacturing engineer IQOQPQ Gage R&R control plans.
We are seeking a Manufacturing or Quality Engineer with 5 8 years of experience to support FDA remediation activities and risk alignment efforts across manufacturing and supplier processes. This role will focus on evaluating design and process risk validating manufacturing controls and ensuring alignment between DFMEAs PFMEAs and real-world manufacturing practices. This position will support remediation activities stemming from a recent FDA Warning Letter and address gaps created by historical acquisitions where DFMEAs and processes were not consistently revised.
Skills & Experience MUST HAVE
Review and interpret DFMEAs PFMEAs and assess alignment with current manufacturing processes
Identify inconsistencies between documented risk and actual process controls
Execute and support IQ/OQ/PQ for manufacturing and supplier processes
Troubleshoot manufacturing and quality issues impacting risk or compliance
Bachelors degree in Engineering (Manufacturing Mechanical Biomedical Chemical or related)
5 8 years of experience in Manufacturing Engineering or Quality Engineering within medical devices
Preferred Experience:
FDA inspections or Warning Letter remediation
CAPA investigations and root cause analysis
