Process Development Contractor

Job Title: Process Development Contractor

Company: Intellectt

Location: Minnetonka, MN

Duration: 6months+

Working Hours: 8:00 AM 5:00 PM

Job Summary:

Intellectt is seeking a Process Development Contractor with 1 3 years of experience in the medical device industry to support process development, validation, equipment implementation, and continuous improvement activities. The ideal candidate will have a strong understanding of engineering principles and experience with process validations, manufacturing documentation, equipment specifications, and data analysis. This role will involve collaborating with cross-functional engineering teams to improve manufacturing processes, ensure regulatory compliance, and enhance product quality, safety, and operational efficiency.

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)..
• Develop and execute Design of Experiments (DOE), validation activities, testing, and data analysis for continuous improvement.
• Suggest and support new methods, materials, and processes to improve quality and operational efficiency.
• Evaluate existing equipment for process suitability and develop detailed improvement plans.
• Create and revise manufacturing documents, specifications, Standard Operating Procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documentation...
• Provide training and process expertise in areas such as process development, tooling development, and validation.

Required Qualifications:

• Bachelor's degree in Engineering or a related technical field.
• 1 3 years of relevant experience preferred.
• Medical device industry experience required.
• Understanding of engineering principles, concepts, practices, and techniques.
• Experience with process development and validation activities.
• Ability to analyze data, troubleshoot problems, and support continuous improvement initiatives.
• Experience creating and revising technical and manufacturing documentation.
• Strong communication and cross-functional collaboration skills.

Preferred Qualifications:

• Experience with Test Method Validation (TMV) and Inspection Method Validation (IMV).
• Knowledge of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).
• Experience with Design of Experiments (DOE), equipment qualification, and process improvement.
• Experience with manufacturing equipment, tooling development, and validation.
• Familiarity with risk assessments, SOPs, and regulated manufacturing environments.

Pay Range: $30-33/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.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.