Sr. Process Development Engineer

About the role

This Sr. Engineer, Process Development position sits within a functional silicone process engineering group and is responsible for designing, developing, documenting, and validating new customer components and modifications to existing products. The role focuses on prototypes, process development, design verification, engineering builds, training production, and preparation for process validation and manufacturing transfer.

Responsibilities

• Attend and arrange project meetings to discuss current and future design and development initiatives.
• 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.
• Prepare and maintain 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.
• Act 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.
• Use statistical data analysis and DOE in process problem solving and process/product improvement.
• Collaborate with tooling engineers and the tool build center for the design and delivery of effective extrusion tooling.
• Collaborate with the material science team and customer on identifying ideal silicones for component design and process optimization.
• Provide 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
• Participate 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.

Requirements

• 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, technical writing, material properties, good tooling practices, and statistics.
• Willingness to travel as needed.

Pay

$115,000 – $135,000 per year