Job Summary:

Seeking a Research and Development Engineer to support process development and engineering activities within a medical device manufacturing environment. The role will focus on process validation, equipment implementation, testing, data analysis, and continuous improvement. The ideal candidate will apply engineering principles to develop practical solutions while maintaining quality, safety, and regulatory compliance.

Key Responsibilities:

• Author and execute Process Validations, including test method, inspection method, installation, operational, performance, and product performance qualifications.
• Support process development, equipment specification, acquisition, implementation, and process suitability assessments.
• Apply engineering principles to analyze technical problems and develop effective solutions.
• Design and execute experiments, validation activities, testing, and data analysis to support continuous improvement.
• Analyze manufacturing equipment and develop detailed improvement plans to enhance process performance and efficiency.
• Develop and revise Standard Operating Procedures, manufacturing documents, specifications, validation protocols, risk assessments, safety instructions, and other technical documentation.
• Collaborate with engineers, technicians, and cross functional teams to develop improvements to materials, equipment, and manufacturing processes.
• Recommend and support new methods, materials, and process improvements that enhance quality and operational efficiency.
• Participate in engineering and continuous improvement teams while supporting safety, quality, and compliance objectives.
• Provide technical training and process expertise related to process development, tooling development, and validation activities.
• Communicate technical information and validation results to equipment teams and internal and external stakeholders.

Required Qualifications:

• Bachelor’s degree in Engineering or a related technical discipline is preferred.
• One to three years of engineering experience in a technical or manufacturing environment.
• Experience within the Medical Device industry is required.
• Knowledge of engineering principles, theories, concepts, practices, and techniques.
• Experience with process development, validation, testing, and technical documentation.
• Strong analytical and problem solving skills with the ability to interpret technical data.
• Ability to collaborate effectively with engineers, technicians, and cross functional teams.

Preferred Qualifications:

• Experience with Process Validation and qualification activities.
• Experience with Design of Experiments and continuous improvement methodologies.
• Familiarity with equipment development, tooling development, and manufacturing process improvement.
• Experience preparing validation protocols, risk assessments, standard operating procedures, and engineering documentation.

If interested kindly share your resume at gagandeep.singh@collabera.com

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 off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $30/hr to $38/hr