Manufacturing Engineer
Job Description
Manufacturing Engineer
Location: Arden Hills, MN (Onsite)
Industry: Medical Device Manufacturing
Employment Type: Contract (12-month rolling contract)
About the Role
Join a dynamic, high-impact engineering team that designs and manufactures lithium batteries and fixtures for pacemakers and defibrillators—products that directly improve and save lives. This position focuses on process development and validation in a high-volume manufacturing environment. It's ideal for an engineer who is hands-on, methodical, and committed to maintaining the highest quality standards.
Key Responsibilities
- Lead and execute validation activities, including IQ, OQ, PQ, TMV, and SAT
- Support the design and integration of batteries and fixtures into implantable medical devices
- Set up and optimize production lines to support scaling and efficiency
- Collaborate cross-functionally with engineering, quality, and production teams
- Write and maintain key manufacturing documentation (validation protocols, test plans, FMEAs, BOMs, work instructions, etc.)
- Troubleshoot issues in production and propose timely, effective solutions
- Ensure quality control is prioritized, even if it impacts timelines
- Proactively communicate progress and challenges—this role values transparency and ownership
Required Qualifications
- Bachelor’s degree in Mechanical Engineering or related field
- 5+ years of experience in a manufacturing or process engineering environment
- Strong expertise in manufacturing process validation (IQ, OQ, PQ, TMV, etc.)
- Background in setting up or improving production lines
- Understanding of automation systems, including robotics, vision systems, servos, and industrial communication protocols
- Ability to work independently, manage your own schedule, and communicate updates without being prompted
- Strong focus on quality control, attention to detail, and continuous improvement
Qualifications
- Experience working in medical device or other highly regulated industries
- Familiarity with AutoCAD or SolidWorks (not a core requirement)
- Experience designing fixtures and precision tooling
- Exposure to automated machine vision systems (e.g., Cognex)
What Makes This Opportunity Unique
- Contribute to products that directly impact patient health and safety
- Be part of a team that values quality over speed—you’ll have the time and support to get it right
- High-visibility role with meaningful ownership over processes and validation efforts
- Onsite role in a collaborative environment with access to hands-on project
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