Research And Development Engineer

Job Title: R&D Engineer

Location: Minnetonka, MN - 55345

Job Overview:

We are seeking a skilled R&D Engineer to join the Process Development Team within the R&D department. The engineer will play a key role in developing and refining manufacturing processes for new product development.

Key Responsibilities:

• Develop, test, validate, and optimize manufacturing processes for new product development.
• Conduct test method validation (TMV/IMV), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Troubleshoot and resolve issues related to process optimization and production efficiency.
• Collaborate with cross-functional teams including engineering, manufacturing, and quality departments.
• Define and document equipment specifications and support equipment qualification.
• Perform test and inspection method validation to ensure compliance with regulatory standards.
• Utilize data analysis tools to assess process performance and drive improvements.

Required Qualifications:

• Education: Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
• Experience: 5-6 years in process development, manufacturing, or R&D.
• Industry Experience: Strong preference for candidates with experience in the medical device industry.
• Technical Skills:
• Process development & validation (including TMV, IMV, IQ, OQ, PQ).
• Equipment development and qualification.
• Manufacturing process optimization.
• Data analysis and problem-solving (Minitab experience is a plus).