Location: Northwest Metro – Minneapolis, MN Type: 6-Month Contract-to-Hire
We are seeking a Manufacturing Operations Senior Technician to support lab-based manufacturing and process development activities related to tissue used in a structural heart medical device. This role is hands-on and focused on executing established processes, supporting development efforts, and maintaining compliance with GMP requirements for sterile medical device manufacturing.
The ideal candidate has experience working in regulated manufacturing or lab environments, is comfortable following detailed procedures, and collaborates effectively with Engineering, Quality, and Regulatory teams.
Execute lab-based manufacturing and process development activities supporting tissue processing of mammalian pericardium
Perform production runs and follow established work instructions, protocols, and SOPs
Support process improvements by identifying issues, documenting observations, and providing input to engineering and development teams
Assist with the development and maintenance of tissue-specific manufacturing procedures and in-process controls
Accurately document manufacturing activities in compliance with GMP requirements
Communicate clearly with cross-functional partners including R&D, Quality, and Regulatory Affairs
Support continuous improvement initiatives within manufacturing and process development
Assist with preparation and review of technical documentation such as protocols, reports, and development records
Perform additional tasks as assigned to support manufacturing operations
3–5 years of experience in manufacturing or laboratory environments within a regulated industry
Experience working under GMP, FDA QSR, or ISO 13485 preferred
Prior experience with tissue processing or mammalian biological materials strongly preferred
Strong attention to detail and ability to follow written procedures
Effective written and verbal communication skills
Ability to work collaboratively in cross-functional teams
Ability to work in a fast-paced, hands-on manufacturing or lab environment
Willingness and ability to work in cleanroom settings
Comfortable handling mammalian tissue and working with biological materials
Ability to manage multiple tasks while maintaining quality and compliance
Responsible for executing assigned manufacturing and process development tasks related to tissue production
Accountable for following approved procedures and maintaining accurate documentation
Works under the direction of engineering or senior technical staff to support product quality and patient safety
