We are looking for a hands-on Manufacturing Engineer with a strong technical and operational focus, capable of leading implementations, validating processes, and collaborating with cross-functional teams. This role requires an active presence on the production floor, strong documentation skills, and excellent communication for effective client and team interaction.
Requirements
Responsibilities:
- Execute process and equipment validations (IQ, OQ, PQ).
- Develop equipment specifications and fixture drawings as part of project requirements.
- Manage change controls, technical documentation, procedures, and protocols.
- Provide on-site technical support and train operators during new implementations.
- Support internal audits and ensure regulatory compliance.
- Coordinate and analyze engineering tests; propose data-driven improvements.
- Collaborate with R&D, Quality, Production, and Supply Chain teams.
- Participate in root cause investigations (CAPAs, complaints).
- Maintain effective client communication and ensure technical alignment.
- Support new product introductions and ongoing process improvements.
Requirements:
- Bachelor’s degree in engineering (Industrial, Chemical, Biomedical, or related field).
- 2–4 years of experience in regulated manufacturing environments.
- Intermediate to advanced English level (minimum B2, ideally C1).
- Experience creating equipment specifications and fixture drawings (must).
- Strong experience with process validations (IQ, OQ, PQ) and documentation.
- Hands-on approach and strong presence on the production floor.
- Knowledge of line procedures and change control processes.
- Excellent communication, negotiation, and customer service skills.
- High adaptability, problem-solving ability, and teamwork orientation.
Other open roles at Nextern(6)
Nextern is a collaborative medical device design company that designs, develops, and manufactures best-in-class medical devices with locations in Minnesota, Costa Rica, and Asia.
Key team members

Wesley Omer

John Hastings

Kevin Kopp

Tammy (Dayton) Chamberland
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