Research And Development Engineer

Intellectt Inc; Minnetonka (MN); On-site; USD 41,000 - 48,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Savings

PTO

Job summary

Intellectt Inc. seeks an R&D Engineer in Minnesota to support process development, validation, and continuous improvement in the medical device industry. You will author validations, develop DOE studies, and create technical documentation.

Responsibilities include equipment specification, process analysis, and cross-functional collaboration to improve product quality and manufacturing efficiency. Experience with TMV/IMV/IQ/OQ/PQ/PPQ is preferred.

Qualifications

• 1–3 years of relevant experience.
• Previous experience in the medical device industry is required.
• Understanding of engineering principles, concepts, practices, and techniques.

Responsibilities

• Author and execute process validations, including TMV, IMV, IQ, OQ, PQ, and PPQ.
• Support process development, equipment specification, acquisition, and implementation.
• Apply engineering principles and technical concepts to analyze and resolve process-related problems.
• Develop and execute DOE, validation activities, testing, and data analysis for continuous improvement.
• Present validation results, testing outcomes, and improvement recommendations to equipment teams.
• Identify and support new methods and materials to improve product quality and manufacturing efficiency.
• Evaluate existing equipment for process suitability and develop detailed improvement plans.
• Create and revise manufacturing documents, specifications, SOPs, safety instructions, validation protocols, risk assessments, and other technical documentation.
• Collaborate with engineers and technicians to develop solutions and improvements related to materials, equipment, and manufacturing processes.
• Participate in cross-functional teams to support continuous improvement, safety, and regulatory compliance.
• Provide training and technical expertise in process development, tooling development, and validation.
• Interact with internal and external customers and cross-functional stakeholders.

Skills

Data analysis

Problem solving

Communication skills

Education

Bachelor's degree in Engineering or related field

Tools

TMV/IMV/IQ/OQ/PQ/PPQ

Job description

We are seeking a R&D Engineer with experience in the medical device industry to support process development, equipment implementation, process validation, and continuous improvement activities. The ideal candidate should have a strong understanding of engineering principles, manufacturing processes, validation methodologies, and technical documentation.

Key Responsibilities

• Author and execute process validations, including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).
• Support process development, equipment specification, acquisition, and implementation.
• Apply engineering principles and technical concepts to analyze and resolve process-related problems.
• Develop and execute Design of Experiments (DOE), validation activities, testing, and data analysis for continuous improvement.
• Present validation results, testing outcomes, and improvement recommendations to equipment teams.
• Identify and support new methods and materials to improve product quality and manufacturing efficiency.
• Evaluate existing equipment for process suitability and develop detailed improvement plans.
• Create and revise manufacturing documents, specifications, SOPs, safety instructions, validation protocols, risk assessments, and other technical documentation.
• Collaborate with engineers and technicians to develop solutions and improvements related to materials, equipment, and manufacturing processes.
• Participate in cross-functional teams to support continuous improvement, safety, and regulatory compliance.
• Provide training and technical expertise in process development, tooling development, and validation.
• Interact with internal and external customers and cross-functional stakeholders.

Required Qualifications

• 1–3 years of relevant experience.
• Previous experience in the medical device industry is required.
• Understanding of engineering principles, concepts, practices, and techniques.
• Knowledge of manufacturing processes and process validation methodologies.
• Ability to analyze data, troubleshoot problems, and develop process improvements.
• Experience preparing and maintaining technical documentation.

Preferred Qualifications

• Bachelor's degree in Engineering or a related field.
• Experience with TMV, IMV, IQ, OQ, PQ, and PPQ.
• Exposure to Design of Experiments (DOE), equipment qualification, and process improvement activities.
• Strong analytical, problem-solving, and communication skills.

Work Requirements

• Ability to collaborate with engineering, manufacturing, and cross-functional teams.

Pay Range: $30-35/hr on W2

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options are available through a third‑party provider. Employees are responsible for paying the full cost of their insurance premiums.
• Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

We are an equal opportunity employer and consider all qualified applicants without regard to legally protected characteristics.