Job Description
Manufacturing Engineer
Logistics:
Location: Arden Hills, MN
Duration: 12+ Month Contract-to-hire
Start Date: ASAP
Onsite Monday-Friday
Citizenship: USC or Green Card Required
Overview
We are seeking a Manufacturing Engineer to join a high-volume team responsible for producing lithium batteries used in pacemakers and defibrillators—two of the company’s highest-value product lines. This is a critical backfill role with significant visibility and impact on quality, cost, and operational excellence.
The ideal candidate will prioritize precision and quality over speed, ensuring processes are executed correctly and thoroughly in a highly regulated medical device environment.
Business Objective
This team designs and manufactures lithium batteries and the fixtures that secure them within pacemakers and defibrillators. These product lines represent two of the largest value streams within the organization. The Manufacturing Engineer will play a key role in supporting validation efforts, new production line setup, and continuous process improvements.
Key Responsibilities
- Lead and execute validation activities including IQ, OQ, PQ, and process validations
- Develop and execute validation protocols and scripts
- Support the design and setup of new production lines
- Collaborate with engineering and operations teams to ensure manufacturing readiness
- Identify process gaps, troubleshoot issues, and implement sustainable solutions
- Ensure strict adherence to quality standards and regulatory requirements
- Proactively communicate project status, risks, and roadblocks
- Maintain strong attention to detail to minimize scrap and prevent quality issues
Required Qualifications
- 5+ years of manufacturing engineering experience, preferably in medical device or regulated industries
- Strong experience with IQ/OQ/PQ and process validation
- Experience setting up new production lines
- Background in mechanical engineering preferred (vs. chemical/electrical focus)
- Understanding of automation systems
- Ability to work independently and manage workload effectively
- Strong communication skills and proactive problem-solving approach
- High attention to detail and commitment to quality
Nice to Have:
- AutoCAD
- SolidWorks