Equipment Engineer II - Exempt

The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies –from design to implementation - while adhering to policies, using specialized knowledge and skills. Responsibilities may include the following and other duties may be assigned: Evaluates, selects and orders equipment that is most appropriate and cost effective for the manufacture of company products.

Join our dynamic team in Minneapolis, MN, a vibrant city known for its cultural landmarks and thriving industries. We are seeking a talented individual to contribute to our cutting-edge projects and innovative solutions.
Must Have

• Experience in equipment IQ
• Process Validation Lifecycle (from process characterization, OQ to PQ)

Nice to Have

• Computer and software validation
• Change control of Medical Devices

Top 3 Required Skill Sets

• Equipment qualification and validation experience, including IQs and tool qualifications
• Protocol and report writing for validation deliverables
• Experience supporting automation and manufacturing equipment in a regulated environment

Main Responsibilities/Day-to-Day Activities

• Write, execute, and document validation protocols and reports
• Support equipment development and validation documentation for manufacturing systems and utilities
• Coordinate validation deliverables, including TMVs, with engineering, quality, and operations

Products Supported
Sinus implants from the Propel and Sinuva product families in ENT
Target Years of Experience
3 to 4 years of relevant experience in equipment engineering, validation, automation support, or related manufacturing work
Interview and Start Date
We plan to begin interviewing immediately after reviewing resumes from the supplier, with an immediate start preferred.
Work Location
Onsite only
Additional Responsibilities
Responsibilities may include the following and other duties may be assigned:

• Evaluates, selects and orders equipment that is most appropriate and cost effective for the manufacture of company products.
• Oversees the installation, modification, upgrade and maintenance of manufacturing equipment.
• Maintains current records on equipment manufacturers'technical notices, upgrades and safety issues.
• Studies equipment performance and reliability.
• Establishes programs and solutions for increasing uptime and for equipment problems that affect the manufacturing process.
• Provides technical support to the manufacturing equipment repair and process engineering organizations.
• Defines and writes preventative maintenance schedules.

Technical Specialist Career Stream
An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies –from design to implementation - while adhering to policies, using specialized knowledge and skills.
Differentiating Factors

• Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
• Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues in order to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employee in Support Career Stream.

Required Knowledge and Experience
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. §214.2(h)(4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.