Sr. Process Development Engineer

About the role

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.

Key Responsibilities

• Attends and arranges project meetings to discuss current and future design and development initiatives
• Serves as a primary contact with clients on projects of moderate complexity
• Affords assistance in preparing proposals and quotations for clients; interfaces as needed to resolve questions in a timely manner
• Affords assistance in preparing and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions
• Tracks and communicates project status, plans, issues, timelines, action items, and budgets
• Serves as the subject matter expert(SME) for silicone extrusion within the Cirtec Plant network
• Provides guidance and direction to coworkers on areas of technical expertise
• Troubleshoots production processes as required
• Evaluates and selects appropriate test methods for product requirements
• Proficient use of statistical data analysis and DOE in process problem solving and process/product improvement
• Collaborates with tooling engineers and tool build center for the design, delivery of effective extrusion tooling
• Collaborates 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
• Reliable, consistent, and punctual attendance is an essential function of the job

Must Have

• 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)
• Maintains high ethical standards
• Demonstrates good organizational skills
• Able to train new engineering employees on project engineering activities and Cirtec policies and procedures
• Able to read, write and speak fluent English
• Strong computer skills, including the MS Office suite and MS Project
• Able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents
• Strong analytical skills
• Able to learn and apply new technology
• Knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics
• Willingness to travel as needed

Salary Range

$115,000 - $135,000 / Annual

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match