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