7 executive assistant jobs found in Maple Grove, MN

Design Quality Engineer Job Description: The Design Quality Engineer leads design control efforts to develop new and improve existing medical devices. This role involves close collaboration with various functions, including R&D and Product Development core teams, to ensure appropriate design controls are established and achievable. Additionally, the position supports process development, manufacturing-related design changes, maintaining regulatory compliance, manufacturability improvements, and cost reduction efforts. Responsibilities: Own the creation and implementation of all design control deliverables. Lead on-time Design Verification and Design Validation and support Process Validation IQ/OQ/PQ/PPQ planning and execution. Actively participate in and contribute to core team and customer-facing meetings. Drive the meaningful translation of user requirements into discrete, objective, measurable, verifiable, and traceable product requirements....

R&D Test Technician Job Description: The R&D Test Technician will support the engineering team in the hands-on build, assembly, testing, and troubleshooting of medical devices and associated fixtures. This role is critical to ensuring high-quality prototype builds, precise test execution, and reliable documentation in support of design verification, process validation, and product development activities. The ideal candidate is an experienced, detail-oriented technician who is comfortable working in a regulated medical device environment and can collaborate effectively with engineers, quality professionals, and manufacturing teams. Responsibilities: Build and assemble medical devices and associated fixtures. Perform testing and troubleshooting of prototypes. Ensure high-quality prototype builds and precise test execution. Document and support design verification and process validation activities. Collaborate with engineers, quality...

Packaging/Labeling Engineer Job Description: This position serves as the packaging and labeling subject matter expert responsible for defining, designing, verifying, and documenting all packaging and labeling solutions for a complex medical device system, including capital equipment, reusables, disposables, and multi-component kits. This role requires a high level of autonomy, technical depth, and familiarity with medical device regulatory requirements. Responsibilities: Serve as the sole subject matter expert for packaging design across capital, reusable, disposable, and kit-based device configurations. Develop protective packaging solutions in compliance with applicable packaging, distribution, and sterilization standards. Create packaging specifications, drawings, CAD models, and BOMs for all packaging components. Select materials and evaluate designs based on performance, manufacturability, and cost. Integrate packaging with sterilization,...

Seeking an OT Analyst to deploy asset inventory identification system to help understand deployed technologies in manufacturing. Defines operational technology systems and operational technology processes by using appropriate methods and tools. Partnering with business and manufacturing customers to understand requirements. Supports implementation of operational technology systems and processes by creating and communicating well-written documentation and presentations. Developing and executing test specifications, and implementing project and quality plans, while working with quality assurance analysts to improve quality processes. Creates and provides training material for user assistance and system usage. Resolves issues related to manufacturing use of implemented systems or processes by working with systems or manufacturing owners to find acceptable solutions. May support multiple project activities simultaneously, working with internal and external cross-functional groups....

Quality Assurance Specialist Job Description The Quality Assurance Specialist is responsible for providing quality support to the pharmaceutical products portfolio, including products in development. This role acts as a quality liaison with cross-functional groups to facilitate continuous improvement, change management, risk management, and issue resolution. Responsibilities Perform executed batch record reviews and product disposition of finished products during product development and/or internal commercial operations. Create and revise Standard Operating Procedures (SOPs) as needed. Execute and approve investigations (e.g., complaints and deviations). Review and approve product-related documents including specifications, master batch records, change control documents, CAPA, investigations, deviations, regulatory submissions, and stability protocols. Assist Operations in situations requiring deviations or investigations. Assist with...

Job Title: Senior Quality TechnicianJob Description We are seeking a Manufacturing Quality Senior Technician/Engineer to support the process development of tissue processing and implement quality inspections. The ideal candidate has hands-on experience with structural heart implants and quality inspection processes, and understands GMP requirements for the manufacture of a sterile medical device. Responsibilities Execute lab-based process development runs in a laboratory setting to develop tissue processing of bovine pericardium. Implement quality controls during process development to ensure tissue performance, biocompatibility, and repeatability. Establish tissue-specific manufacturing procedures, inspection criteria, and in-process controls. Develop and maintain relationships with testing vendors for ongoing testing and process development characterization. Maintain test schedules and coordinate sample drop-off and pickup. Review technical...

Job Description The Process Engineer II will play a key role in supporting process development and product commercialization across the organization's global plant network. Working in a fast-paced, cross-functional environment, this individual will partner with R&D to define design specifications, develop test methods, and drive material selection while providing Design for Manufacturability input. Responsibilities include innovating and implementing new processes, tooling, and automation; overseeing prototype and initial production builds; authoring and reviewing validation protocols; and ensuring compliance with quality system requirements. The role requires strong engineering fundamentals, problem-solving skills, and the ability to collaborate across functions to deliver efficient product transfers into production. Preferred candidates will bring experience with extrusion processes, polymers, equipment development, DFSS tools, and regulated industry practices, along with...