Manufacturing Engineer

KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.

Job Title: Manufacturing Engineer

Location: Plymouth, MN

Position Summary

We are seeking a highly motivated Manufacturing Engineer with a background in medical device manufacturing to join our team in Plymouth, MN. The ideal candidate will play a critical role in driving process improvements, supporting new product introductions, ensuring regulatory compliance, and optimizing production efficiency in a regulated environment.

You will collaborate cross-functionally with R&D, Quality, Supply Chain, and Production teams to develop robust manufacturing processes that ensure high quality, cost-effective, and compliant products.

Key Responsibilities:

• Process Development & Optimization Design, develop, validate, and optimize manufacturing processes for new and existing products in accordance with FDA regulations and ISO 13485 standards.
• Conduct time studies, capacity analysis, and root cause analysis for process improvement and troubleshooting.
• Develop and implement manufacturing work instructions, routings, and process flow diagrams.
• New Product Introduction (NPI)
• Act as a core team member for new product development projects to ensure manufacturability and smooth transition from development to production.
• Support design for manufacturability (DFM) and design for assembly (DFA) efforts.
• Equipment & Tooling
• Specify, procure, qualify, and validate manufacturing equipment, fixtures, and tooling.
• Ensure preventive maintenance and calibration systems are in place for critical tools and equipment.
• Regulatory Compliance & Documentation
• Prepare and maintain documentation for process validations (IQ, OQ, PQ), risk assessments (FMEA), and change control.
• Support internal and external audits by providing technical documentation and responding to audit findings.
• Continuous Improvement
• Lead or participate in lean manufacturing, Six Sigma, and Kaizen initiatives to enhance efficiency, reduce waste, and improve product quality.
• Drive cost-reduction and yield improvement initiatives.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field.
• Experience:
• 3–5+ years of experience in a manufacturing engineering role, ideally in the medical device industry.
• Hands-on experience with GMP, FDA 21 CFR Part 820, and ISO 13485.
• Strong background in process validation (IQ, OQ, PQ) and design controls.

Skills:

• Proficiency in CAD software (SolidWorks preferred).
• Experience with ERP and MES systems.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication and cross-functional collaboration abilities.

Benefits:

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)