Manufacturing Engineer II - Exempt

Join our dynamic team in Plymouth, MN, where innovation meets precision in the heart of the manufacturing industry. We are seeking a talented individual to support our production of Mechanical Heart Valves, ensuring quality and efficiency in our processes.

Must Have:

• Investigation and root cause analysis skills
• Technical writing knowledge
• Organization and Communication skills
• Process Validation and Computer software validation knowledge
• Daily operations support

Nice to Have:

• Experience in validation and performance analysis (MSA, IQ/OQ/PQ, TMV)
• Ensuring regulatory compliance and reliability

Responsibilities:

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Design arrangement of machines within plant facilities for optimal efficiency and productivity.
• Design sequence of operations and specify procedures for tool and equipment fabrication affecting product performance.
• Adapt machine or equipment design to factory and production conditions.
• Incorporate inspection and test requirements into the production plan.
• Inspect machinery, equipment, and tools for efficiency and initiate corrective actions for product quality.
• Develop manufacturing processes applicable to statistical process control.
• Provide guidance to engineering regarding design concepts and specification requirements.
• Ensure processes and procedures comply with regulations.

Additional Position Details:

• Top 3 skill sets required: Production support, communication, critical thinking
• 3 main responsibilities/day-to-day activities: Day-to-day production floor support, NCMR processing, CAPA processing
• Target years of experience: 1-5 years of experience
• Start date: Hire and Start ASAP
• Work location: Onsite in Plymouth, MN

Required Knowledge and Experience:

Requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.