Cirtec Medical

Sr. Project Engineer

Cirtec Medical$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a STEM field
  • 5+ years of experience in a Project Engineer role
  • Familiarity with project management methodologies
  • Proficient in validation protocols (IQ, OQ, PQ)
  • Knowledge of Geometric Dimensions and Tolerancing (GD&T)
  • Experience with quality management systems
  • Strong computer skills including MS Office, MS Project, AutoCAD, and SolidWorks

Responsibilities

  • Lead the NPI process from concept to commercialization
  • Collaborate on design for manufacturability and production efficiency
  • Interface with customers on part requirements and mold designs
  • Develop and maintain detailed project plans with milestones
  • Coordinate cross-functional teams for NPI alignment and execution
  • Conduct feasibility studies and risk assessments for projects
  • Collaborate with suppliers for timely material and tooling availability
  • Design and execute validation and verification plans
  • Drive continuous improvement initiatives for process optimization
  • Maintain accurate documentation for NPI activities
  • Provide regular project updates to management and stakeholders
  • Utilize 3D modeling software for project assessment
  • Create cost estimates for tooling and machinery
  • Oversee prototype and material development projects

Benefits

  • Opportunities for professional growth and development
  • Collaborative work environment
  • Exposure to cross-functional teams
  • Engagement with cutting-edge manufacturing processes
  • Potential for travel to support project needs
Full Job Description
Description

Position Summary:

The Sr. Project Engineer is primarily responsible for leading a cross functional project team that includes Quality, Engineering and Production. This position oversees the development, documentation and validation of new and modified customer products by maintaining established timelines, communication of project status internally and to customers. They also manage transferring projects to Production with a cradle to grave philosophy for programs. The Sr. Project Engineer must meet agreed upon delivery dates and established product requirements while ensuring the greatest level of manufacturability for products transferred to Production. This position will work closely with members of the Quality Assurance, Manufacturing, Tooling, Materials Science and Process Engineering teams to deliver projects to help achieve organizational goals. They will also work individually and on teams to execute organizational projects for continuous improvement in various manufacturing processes.

Key Responsibilities:

  • Lead and manage the entire (NPI) New Product Introduction process from concept to commercialization ensuring effective collaboration among all stakeholders.
  • Collaborate closely 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 and mold designs and may 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 including 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 appropriate mitigation strategies.
  • Collaborate with suppliers and vendors to ensure timely availability of materials tooling and equipment necessary 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). Generate validation completion reports with cross-functional team including quality and metrology department. Final reports to include:
    • Develop 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 form a better understanding of customer supplied models for quoting and/or tooling builds.
  • Create quotations on estimated costs for tooling, automation and machinery required for a successful product launch.
  • Oversee prototype and material development projects.
  • Involvement in design and development of new projects.
    • Prototyping
    • Part and tool design verification
  • Provide engineering support to manufacturing on existing product lines as necessary.

Must Have:

  • A Bachelors 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 is required.
  • Understanding of quality management systems and experience in implementing quality assurance processes.
  • Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced manufacturing environment.
  • Strong computer skills including the MS Office suite, MS Project, AutoCAD and SolidWorks.
  • Must be able to fully interpret technical drawings, specifications, illustrations and written documents.
  • Must be able to read write and speak fluent English.
  • Must demonstrate good organizational skills.
  • Strong analytical skills.
  • Willingness to travel if required.
  • Experience in molding methods is a plus.


About Cirtec Medical

Cirtec Medical is a medical device company that designs, develops, and manufactures implantable medical devices and components. The company's products are used in a variety of medical applications, including cardiovascular, orthopedic, and neurological procedures. Cirtec Medical was founded in 2014 and is headquartered in Irvine, California.
Learn more about Cirtec Medical
Size
1,000 employees
Industry
Founded
2009

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