Manufacturing Engineer at Resource Logistics
Listed on 2026-10-20
-
Engineering
Manufacturing Engineer, Quality Engineering, Validation Engineer, Process Engineer
Location: Plymouth, MN
Work Arrangement: 100% Onsite
Contract: Contract
Experience
Required:
5+ years
We are seeking an experienced Manufacturing Engineer with a strong background in medical device manufacturing to support manufacturing engineering, new product introduction, process development, process validation, tooling, and equipment development.
The ideal candidate will have hands‑on experience working in regulated medical device manufacturing environments and be comfortable collaborating with Engineering, Quality, R&D, Operations, and other cross‑functional teams
Required ExperienceMust have 5+ years of professional Manufacturing Engineering experience.
Candidates should have hands‑on experience with several of the following:
5+ years of Manufacturing Engineering experience
Medical device manufacturing experience
New Product Introduction (NPI) / New Product Development
Manufacturing process development and optimization
Process characterization
Process validation, including IQ/OQ/PQ
Test method development and validation
Inspection method development and validation
Test fixture and tooling design/development
Manufacturing equipment development and qualification
Design for Manufacturability (
DFM
)
Manufacturing readiness and process scale-up
Understanding of the product development lifecycle
Cross-functional collaboration with R&D, Quality, Operations, and Engineering teams
Experience working in regulated manufacturing environments
Preferred Medical Device ExperienceExperience with
Class I, II, or III medical devices is strongly preferred.
Experience with regulated quality systems and standards such as:
FDA 21 CFR Part 820
ISO 13485
GMP/cGMP
Design controls
PFMEA/DFMEA
CAPA
Statistical process control
EducationBachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline required
Master's degree preferred
What You’ll DoDevelop and improve manufacturing processes for medical device products.
Support NPI and new product transfer activities from development through commercialization.
Develop, execute, and document IQ/OQ/PQ process and equipment validation
.
Perform process characterization and capability studies.
Develop and validate manufacturing and inspection test methods.
Design and improve test fixtures, tooling, and manufacturing equipment
.
Support DFM activities and provide manufacturing input during product development.
Develop and maintain manufacturing documentation, procedures, protocols, and reports.
Troubleshoot manufacturing and process issues and implement corrective actions.
Collaborate with cross-functional and global teams to ensure manufacturing readiness.
Support continuous improvement, process optimization, quality, and production efficiency initiatives.
Candidate Requirements5+ years of Manufacturing Engineering experience
Medical device manufacturing experience strongly preferred
Hands‑on IQ/OQ/PQ experience
NPI/NPD experience
Process development and validation experience
Test fixture/tooling experience
Strong technical documentation and problem-solving skills
Bachelor's degree in Engineering
Ability to work 100% onsite in Plymouth, MN
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