To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL [Anwesha Mohapatra Collabera | LinkedIn]Anwesha Mohapatra Collabera | LinkedIn), email your updated resume at Email anwesha.mohapatra@collabera.com. Thank you!

Pay Range: $30/hr to $35/hr

Job Title: R&D Engineer

Location: Minnetonka, MN 55345

Work Type: Onsite

Contract Duration: 06 Months with possible extension

Job Summary:

Seeking an R&D Engineer with 1 to 3 years of experience in the medical device industry. The ideal candidate will support process development, equipment implementation, process validation, testing, and continuous improvement activities. This role requires strong engineering fundamentals and the ability to analyze data, solve technical problems, and develop compliant manufacturing processes. The engineer will collaborate with cross functional teams to improve product quality, process efficiency, equipment performance, and regulatory compliance.

Key Responsibilities:

• Author and execute process validations including Test Method Validation, Inspection Method Validation, Installation Qualification, Operational Qualification, Performance Qualification, and Product Performance Qualification.
• Support process development, equipment specification, acquisition, implementation, and process suitability assessments.
• Develop and execute experiments, validation activities, testing, and data analysis to support continuous improvement.
• Analyze equipment and manufacturing processes and develop detailed improvement plans.
• Create and revise manufacturing documents, specifications, standard operating procedures, safety instructions, validation protocols, risk assessments, and other technical documentation.
• Work with engineers and technicians to develop solutions and improvements involving materials, equipment, and manufacturing processes.
• Present testing and analytical data to equipment and cross functional teams.
• Support continual improvement, safety, quality, and compliance initiatives.
• Provide process expertise and training related to product processing, process development, tooling development, and validation.
• Interact with internal and external stakeholders to support technical and manufacturing objectives.

Required Qualifications:

• Bachelor's degree in Engineering or a related technical field.
• 1 to 3 years of relevant engineering experience.
• Medical device industry experience.
• Experience with process validation and validation documentation.
• Strong understanding of engineering principles, theories, concepts, practices, and techniques.
• Ability to analyze data and solve problems using fundamental engineering principles.

Preferred Qualifications:

• Experience with Design of Experiments and continuous improvement activities.
• Experience with equipment specification, acquisition, implementation, and process suitability analysis.
• Experience developing technical documentation, risk assessments, validation protocols, and standard operating procedures.
• Experience presenting technical data to engineering or equipment teams.
• Experience providing process training and technical support.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)