Process Development Engineer II

at  Merit Medical Systems Inc

Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Summary of Minimum Qualifications:

• Degree in Engineering, related technical field or with appropriate demonstrated experience.
• At least 4 years previous related experience.
• Demonstrated analytical problem-solving abilities.
• Demonstrated ability in Process development, validation and statistical analysis.
• Experience in Metal processing & joining techniques and emerging process technologies an advantage.
• Good working knowledge of medical device materials and processes.
• Working knowledge of Solidworks and / or 3D modeling.
• Formal project management training an advantage.
• Good working knowledge of Microsoft Office including MS Project or similar.
• Strong interpersonal and organizational skills and the ability to work effectively as a team member

Performs routine and complex technical work such as the design, manufacture and operation of structures, machines and systems under broad supervision and guidelines.

Main Duties/Responsibilities:

• Liaise with Project Leaders, R&D & Operations Team members and other internal customers to clearly understand requirements and inputs.
• Investigate, select and develop appropriate materials, vendors, technologies and specifications to ensure that process design is robust and reproducible and capable of meeting all qualification requirements.
• Ensure that Design for Manufacturability, capacity and product cost impacts are considered in all decision making such that design can be scaled seamlessly in to manufacturing at required product cost.
• Define and put in place drawings, BOM’s and Routers and procedure to ensure the product design is translated accurately in to Manufacturing.
• Plan and execute risk assessment, process specification/ test methods development and subsequent Process Qualifications (IQ,OQ,PQ)
• Generate and maintain required Engineering and Design documentation in line with the Quality Management System and associated regulatory requirements.
• Provide Guidance to Junior Engineers and Technicians within the R&D Department.
• Performs other related duties and tasks as required.

Summary of Minimum Qualifications:

• Degree in Engineering, related technical field or with appropriate demonstrated experience.
• At least 4 years previous related experience.
• Demonstrated analytical problem-solving abilities.
• Demonstrated ability in Process development, validation and statistical analysis.
• Experience in Metal processing & joining techniques and emerging process technologies an advantage.
• Good working knowledge of medical device materials and processes.
• Working knowledge of Solidworks and / or 3D modeling.
• Formal project management training an advantage.
• Good working knowledge of Microsoft Office including MS Project or similar.
• Strong interpersonal and organizational skills and the ability to work effectively as a team member.