Manufacturing Engineer

Manufacturing Engineer II

Pay Range: $35/hr to 40/hr

Location:

Minnetonka, MN 55343

Work Type:
Onsite

Contract Duration: 03 to 06 months with possible extension

Job Summary:

• The Manufacturing Engineer II will provide technical leadership and engineering support within a regulated medical device manufacturing environment.
• The role will focus on manufacturing process development, process validation, risk assessment, process controls, and continuous improvement initiatives.
• The engineer will take ownership of complex technical assignments and develop effective solutions where established precedents may not exist.
• The position requires strong collaboration with internal teams, external stakeholders, suppliers, and engineering partners.
• The successful candidate will manage multiple projects while ensuring technical activities, timelines, and deliverables remain aligned with business objectives and quality requirements.

Key Responsibilities:

• Lead complex manufacturing engineering activities and provide technical direction for assigned projects.
• Support manufacturing processes through process validation, process controls, risk assessment, and continuous improvement activities.
• Develop and implement effective engineering solutions for manufacturing challenges while considering impacts across related systems and processes.
• Plan and manage project timelines, deliverables, technical activities, and cross functional dependencies.
• Collaborate with internal stakeholders, external partners, suppliers, quality teams, and engineering groups to resolve technical and operational issues.
• Support supplier changes and assess their impact on manufacturing processes, validation activities, and product quality.
• Participate in peer reviews and provide technical input for verification and validation activities.
• Identify potential manufacturing risks and recommend appropriate corrective and preventive actions.

Required Qualifications:

• Bachelor of Science or Bachelor of Engineering degree in Mechanical Engineering, Electrical Engineering, Software Engineering, or a related engineering discipline.
• Minimum 5 to 6 years of Manufacturing Engineering experience within a Class III medical device environment.
• Strong experience with process validation including IQ, OQ, and PQ.
• Experience with manufacturing risk assessment and process controls.
• Demonstrated experience working with internal and external stakeholders.
• Experience managing project timelines and supporting multiple projects simultaneously.
• Experience working with cross functional teams and managing supplier changes.

Preferred Qualifications:

• Experience supporting complex medical device manufacturing operations.
• Experience implementing new manufacturing methods and approaches.
• Experience with verification and validation activities within a regulated manufacturing environment.
• Experience driving continuous improvement initiatives.

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, paid holidays annually - AS Applicable