Sr. Process Development Engineer

Description About us

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing 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. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

The Sr. Engineer, Process Development position is primarily responsible for working in a functional silicone process engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation, and validation and of new customer components, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, engineering builds, training production, and preparation for process validation and manufacturing transfer of products.

• Attends and arranges project meetings to discuss current and future design and development initiatives
• May serve as a primary contact with clients on projects of moderate complexity.
• Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
• Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
• Serve as the subject matter expert(SME) for silicone extrusion within the Cirtec Plant network.
• Provide guidance and direction to coworkers on areas of technical expertise.
• Troubleshoot production processes as required.
• Evaluate and select appropriate test methods for product requirements.
• Proficient use of statistical data analysis and DOE in process problem solving and process/product improvement.
• Collaborate with tooling engineers and tool build center for the design, delivery of effective extrusion tooling
• Collaborate with material science team and customer on identifying ideal silicones for component design and process optimization.
• Responsible for the following project inputs:
  • Feasibility builds, documentation, and testing
  • Equipment selection, process development and documentation
  • Device Verification samples and testing
  • Operator training
  • Process Failure Mode Effects Analysis
  • Clinical builds
  • Process Validation
• Involvement in the full design, development, and validation requirements of projects, including:
  • Product component design and specification creation, including extrusions, molded assemblies, and packaging.
  • Materials sourcing and equipment prototyping.
  • Process verification and validation activities, including data for regulatory submission.
  • Manufacturing transfer and support of existing product lines as applicable.
• Reliable, consistent, and punctual attendance is an essential function of the job.

• A Bachelor's degree in a STEM engineering discipline
• 5 years of experience in process development engineering
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Must maintain high ethical standards
• Must demonstrate good organizational skills.
• Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
• Must be able to read, write and speak fluent English.
• Strong computer skills, including the MS Office suite and MS Project.
• Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
• Strong analytical skills
• Must be able to obtain and evaluate secondary research information.
• Ability to learn and apply new technology.
• Knowledge of engineering principles,…