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Manufacturing Engineer- Medical Devices
Job Description
Job Description
Manufacturing Engineer- Medical Devices Contract:
Minnetonka, Minnesota, US Salary Range:
30.00 - 40.00 |
Per Hour Job Code:
371578
End Date:
2026-10-10
Days Left:
28 days, 7 hours left
Job Summary:
We are seeking an experienced Manufacturing Engineer to support component qualification projects for Class III medical device products. This position combines hands-on manufacturing engineering with project management, supplier coordination, and cross-functional leadership. The ideal candidate will have experience supporting regulated medical device manufacturing and independently managing engineering projects, timelines, risks, and supplier-related changes.
Key Responsibilities:
Own and execute component and material qualification projects for Class III medical device products.
Develop, maintain, and manage project schedules, milestones, risks, dependencies, and deliverables.
Lead manufacturing engineering projects independently with limited oversight.
Represent Manufacturing and Operations within cross-functional engineering initiatives.
Evaluate the impact of component, material, supplier, and design changes on manufacturing operations.
Coordinate qualification activities, project schedules, and deliverables with internal teams and external suppliers.
Support supplier changes and qualification activities while ensuring alignment with project milestones.
Lead cross-functional project meetings and drive action items through completion.
Support process validation activities, including IQ, OQ, and PQ, along with risk assessments and process controls.
Identify project risks, schedule conflicts, and delays and develop appropriate mitigation plans.
Manage multiple engineering projects simultaneously in a fast-paced manufacturing environment.
Provide clear project status, risk, issue, and progress updates to stakeholders and senior leadership.
Required Qualifications:
Bachelor's degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related engineering discipline.
5+ years of relevant Manufacturing Engineering experience within Class III medical device manufacturing.
Strong hands-on experience with Class III Medical Devices and regulated manufacturing environments.
Demonstrated Project Management experience managing engineering timelines, schedules, milestones, risks, and deliverables.
Experience supporting multiple manufacturing or engineering projects simultaneously.
Experience working with cross-functional teams and internal and external stakeholders.
Knowledge of Process Validation, including IQ, OQ, and PQ.
Experience with Risk Assessment and manufacturing process controls.
Experience supporting supplier changes, component changes, or supplier qualification activities.
Strong proficiency with MS Excel for project tracking and schedule management.
Excellent written and verbal communication skills with the ability to communicate effectively with suppliers and leadership.
Ability to work independently, take ownership of projects, and drive activities through completion.
Preferred Qualifications:
Manufacturing experience involving catheters or similar Class III medical device products.
Experience with Component Qualification and alternate material qualification.
Experience with Supplier Qualification within medical device manufacturing.
Experience using Windchill for manufacturing change control.
Experience using MS Project for project scheduling and timeline management.
Knowledge of Lean Manufacturing, Six Sigma, or GMP manufacturing methodologies.
Experience supporting manufacturing change controls within a regulated environment.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable.
Pay Range:
$30/hr to $40/hr Job Requirement
Class III Medical Devices
Manufacturing Engineering
Project Management
Component Qualification
Supplier Qualification
Process Validation
IQ/OQ/PQ
Risk Assessment
Catheter Manufacturing
Microsoft Excel
Windchill
Microsoft Project
Reach Out to a Recruiter
Recruiter
Phone
Gagandeep Singh
gagandeep.singh@collabera.com
7042475816
Benefits
- Paid Time Off (PTO)
- Sick Leave
- 401(k) Plans
- Other Retirement and Savings