R&D Engineer

Process Development Engineer (R&D - Medical Device)

This role focuses on developing, validating, and improving manufacturing processes for medical devices. The R&D Engineer will author and execute process and test method validations, define and implement process development equipment, and drive continuous improvement activities through data-driven experimentation and analysis. The position requires close collaboration with cross-functional teams and hands-on involvement in documentation, training, and process optimization to ensure compliant, efficient, and safe operations.

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).
• Define specifications for process development equipment and lead the acquisition and implementation of new equipment to support manufacturing processes.
• Apply engineering principles, theories, concepts, practices, and techniques to analyze and solve process-related problems in a medical device environment.
• Design and conduct experiments, complete validation testing, and perform data analysis to support continuous improvement activities.
• Prepare and present data, findings, and recommendations to equipment teams and other stakeholders to support decision-making and process optimization.
• Evaluate current equipment for process suitability and develop detailed plans for improvement in quality, efficiency, and safety.
• Create and revise manufacturing documents, including specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documents to maintain compliant and efficient processes.
• Collaborate with other engineers and technicians to develop solutions and improvements in materials, equipment, and processes as needed.
• Participate in cross-functional teams to drive continual improvement, safety, and regulatory compliance in manufacturing operations.
• Provide training and process expertise for product processing in specific areas such as process development, tooling development, and validation.
• Interact cross-functionally and communicate effectively with internal and external customers to support process development and validation activities.

Essential Skills

• 1–3 years of experience in process development or a related engineering role, preferably within the medical device industry.
• Hands-on experience in medical device manufacturing or development environments.
• Proficiency in authoring and executing process validations, including TMV, IMV, IQ, OQ, PQ, and PPQ.
• Strong understanding of engineering principles, theories, concepts, practices, and techniques relevant to process development.
• Ability to analyze and solve problems using basic engineering principles and data-driven approaches.
• Experience designing experiments, conducting validation testing, and analyzing data to support continuous improvement.
• Capability to create, revise, and maintain technical manufacturing documentation such as SOPs, specifications, safety instructions, validation protocols, and risk assessments.
• Effective collaboration skills to work with engineers, technicians, and cross-functional teams.
• Clear communication skills to present data and interact with internal and external customers.

Additional Skills & Qualifications

• Bachelor's degree in engineering or a related technical field is preferred.
• Experience supporting continual improvement initiatives in manufacturing or R&D environments.
• Familiarity with process development and tooling development in a regulated industry.
• Ability to provide training and guidance on process and validation activities.
• Comfort working with validation and qualification frameworks in medical device or similarly regulated sectors.

Work Environment

The role operates within a medical device development and manufacturing environment that emphasizes safety, compliance, and continuous improvement. Work involves close collaboration with equipment teams, engineers, technicians, and cross-functional stakeholders,…