Sr. Project Engineer

About the role

Cirtec Medical is seeking a Sr. Project Engineer to lead cross-functional project teams in the development, documentation, and validation of new and modified customer products. This role oversees the entire New Product Introduction (NPI) process from concept to commercialization, ensuring projects meet delivery dates, product requirements, and manufacturability standards. The Sr. Project Engineer will collaborate with Quality Assurance, Manufacturing, Tooling, Materials Science, and Process Engineering teams to achieve organizational goals and drive continuous improvement in manufacturing processes.

Responsibilities

• Lead and manage the entire New Product Introduction (NPI) process from concept to commercialization, ensuring effective collaboration among all stakeholders.
• Collaborate with product development teams to provide input on design for manufacturability, cost-effective production processes, and efficient assembly methods.
• Interface with customers regarding part requirements, mold designs, and serve as a primary contact on projects of moderate complexity.
• Develop and maintain detailed project plans, including timelines, milestones, and critical path activities. Track and report progress against established goals.
• Coordinate cross-functional teams (engineering, manufacturing, materials science, procurement, and quality assurance) to ensure alignment and timely execution of NPI activities.
• Conduct feasibility studies and risk assessments to identify potential challenges and propose mitigation strategies.
• Collaborate with suppliers and vendors to ensure timely availability of materials, tooling, and equipment for NPI projects.
• Design and execute validation and verification plans, including process qualifications, equipment validations, and product testing to ensure compliance with quality standards and customer requirements.
• Develop and execute process validations (IQ, OQ, PQ) and generate validation completion reports with cross-functional teams, including quality and metrology departments. Final reports to include:
  • Validation protocol activities
  • Dimensional reports and analysis
  • Engineering studies, DOE, FMEA, Control Plan, Process Flow
  • Confirmation of all validation activities executed, including written procedures
• Drive continuous improvement initiatives to optimize procedures, reduce costs, and enhance product quality and manufacturability.
• Maintain accurate documentation, including engineering change orders, bill of materials, and work instructions to support NPI activities.
• Provide regular project updates to stakeholders, including management, highlighting progress, risks, and proposed solutions.
• Utilize 3D modeling software to examine and interpret customer-supplied models for quoting and/or tooling builds.
• Create quotations for estimated costs of tooling, automation, and machinery required for a successful product launch.
• Oversee prototype and material development projects.
• Participate in the design and development of new projects, including prototyping, part and tool design verification.
• Provide engineering support to manufacturing on existing product lines as necessary.

Requirements

• A Bachelor’s degree in a STEM-related field.
• 5+ years of experience as a Project Engineer or in a similar role within a manufacturing environment.
• Familiarity with project management methodologies and tools, with a track record of successfully managing complex projects.
• Familiarity with validation (IQ, OQ, PQ, PQP, etc.) of equipment and tooling.
• Proficiency in dimensioning and Geometric Dimensions and Tolerancing (GD&T) principles.
• Understanding of quality management systems and experience implementing quality assurance processes.
• Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced manufacturing environment.
• Strong computer skills, including MS Office suite, MS Project, AutoCAD, and SolidWorks.
• Ability to fully interpret technical drawings, specifications, illustrations, and written documents.
• Fluent in English (reading, writing, and speaking).
• Strong organizational and analytical skills.
• Willingness to travel if required.
• Experience in molding methods is a plus.

Benefits

• Training and career development opportunities.
• 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.