Principal Process Development Engineer

About the role

Cirtec Medical has been a leading outsourcing partner for complex medical devices since 20th century. We specialize in comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration.

Position Summary

The Principal Process Development Engineer supports the Process Development Engineering team as a subject matter expert in defining and developing manufacturing processes for medical devices and associated auxiliary equipment. This role deploys Best in Class methods for process characterization, process validation, and process improvement opportunities; collaborates across the Cirtec Medical organization, working with Manufacturing Engineering, Quality Assurance, and Applications Engineering to deliver superior manufacturing processes. The Principal Process Development Engineer is the technical lead and mentor to other Process Development Engineers, assisting management in teaching, guiding, mentoring, and providing technical direction to the Process Development Engineering team.

Key Responsibilities

• Oversee and provide technical direction over Development Engineering of medical device manufacturing processes and transfer to production
• Plan and lead process design initiatives that define, characterize, optimize, and validate stable, robust, and capable processes for product commercialization
• Create test methods and corresponding test method validations
• Lead PFMEA creation and supporting risk management activities
• Capture and coordinate process qualification activities (i.e., IQ, OQ, PQ)
• Define requirements and design criteria, then develop, document, and qualify new (or improve existing) equipment, tooling, and fixturing
• Advise internal and external customers in Design for Manufacturability
• Understand the functional performance of manufacturing processes as they are developed
• Write/update work instructions, part specifications, protocols, and technical documents
• Maintain compliance to procedures and regulatory requirements
• Communicate technical risks as they arise
• Research, evaluate, and recommend equipment, technologies, material, and methodologies that improve quality, reduce costs, and decrease program development time
• Assist, as an available resource, Business Development and Applications Engineering in quoting and proposal development
• Exercise creative problem solving and critical thinking; oversee the planning and execution of DOE/characterization studies, analysis, interpretation, and documenting and reporting of data
• Lead and teach analytical techniques and apply engineering principles to understand the impact and interaction of materials and processes on process and product outputs
• Lead cross-functional teams in collaborative efforts to research, define and develop new manufacturing processes and improve existing processes
• Serve as technical expert in phase or design reviews with internal and external stakeholders
• Improve the engineering development process and systems based on experience and feedback
• Manage workload to support various projects, in larger scale and complexity
• Provide technical subject matter expertise and oversee management and partnerships with external suppliers by executing due diligence assessments, setting specifications for critical quality and/or manufacturing attributes for materials and components, collaborate on development projects and qualification/validate external processes
• Mentor and educate engineers and technicians in various functions; and communicate technical knowledge cross-project to reduce tribal knowledge
• Understand the complete product development process within the medical device industry (Class II & III)
• Support project teams with technical problem solving and expert opinion

Must Have

• A bachelor’s degree (STEM engineering discipline)
• 10 years of experience in process engineering
• Experience and knowledge working under quality management systems that meet governmental regulations such as FDA QSR, ISO 13485, the MDD relevant standards, and have knowledge cGMP, GDP principles and practices
• Familiarity with CAD required, SolidWorks preferred
• Experience with robust process documentation (IQ/OQ/PQ, PFMEA, process flow)
• Knowledge of dimensioning and tolerances, GD&T
• Computer skills associated with Microsoft software
• Must be able to read, write and speak fluent English
• Excellent reading, writing, communication, and organizational skills
• Possess team collaboration skills
• Strong mechanical aptitude
• Good attention to detail
• Knowledge of ISO & FDA requirements
• Experience with LEAN manufacturing

Strong To Have

• Strong attention to detail
• Knowledge of ISO & FDA requirements
• Experience with LEAN manufacturing