More jobs:
Manufacturing Engineer
Job in
Louisville, Boulder County, Colorado, 80028, USA
Listed on 2026-07-18
Listing for:
Bishwa Mahato
Full Time
position Listed on 2026-07-18
Job specializations:
-
Engineering
Quality Engineering, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Title:
Manufacturing Engineer
Location:
Louisville, CO
- Support all phases of Operations MDD/MDR product MDD/MDRTF remediation.
- Operations Supplier (CM/OEM) and continuity engineering tasks.
- Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
- Review of inspection and test requirements within production plans requiring remediation.
- Tech File review.
- Support NCMRs, Paper IFUs (versioning capital, IFU kits MATNRs), PCRs, PCHs, Work Instructions Updates, CAPAS/Corrective Actions from NCMRs, PPAP, providing manufacturing technical support to SQEs, Supplier Process Improvement, Reporting (Pareto NCMRs, trending and insights/Help needed), PCR - Product EOL PCR, Product replacement PCR.
- Control plan review, Inspection Criteria creation, QAC Creation, ECO & SMECO Approval, DCO routing.
- Driving supplier quality performance, including new product development and product quality improvement.
- Qualifies suppliers according to Supplier standards (PPAP
- Production Part Approval Process) and may administer a Certified Supplier Program in receiving inspection. - Evaluates suppliers internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Works with supplier to obtain each deliverable according to the PPAP procedure and evaluate adequacy to the requirements.
- PFMEA, Process controls, MSA, Supplier Validation (IQ/OQ/PQ), Process Capability.
- Providing leadership and management for the supplier quality department.
- Overseeing supplier quality team and establishing quality control objectives.
- Work with R&D and Contract Manufacturer to create Bill of Materials (BOM).
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