Must be local and able to work on-site in Rock Hill, South Carolina.

Compensation range 75K- 90K

ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

JOB SUMMARY

The 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 customer products, by maintaining established timelines, communication of project status, and transferring projects to Production. The 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, and Engineering teams to deliver projects to help achieve organizational goals.

ESSENTIAL RESPONSIBILITIES

• Lead and manage the entire 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, and track progress against established goals.
• Coordinate cross-functional teams, including engineering, manufacturing, 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.
• Perform process validations (OQ & PQ) and develop process control plans to ensure the stability and repeatability of manufacturing processes.
• Drive continuous improvement initiatives to optimize NPI processes, 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 price, tooling costs, automation and machinery required for a successful product launch.
• Oversee prototype projects.
• Involvement in the full design, development, and validation requirements of projects, including:
  • Materials sourcing and prototyping,
  • Design verification and validation activities.
  • Manufacturing support of existing product lines as applicable
• Responsible for the following project inputs:
  • Feasibility requirements, documentation, and testing
  • Equipment selection, process development and documentation support
  • Component verification samples and testing
  • Process Failure Mode Effects Analysis
  • Assist in selecting appropriate validation requirements and provide process validation support.
  • Other duties.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

• A Bachelor’s degree and 2-3 years of experience required; or a combination of education and relevant work experience.
• Proven experience as a Project Engineer or in a similar role within a manufacturing environment, willingly to train the right candidate....
• 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, blueprints, 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.
• Must maintain high ethical standards.

WHAT WE OFFER

• A fast-paced work environment

• Ability to work on life saving products

• 401(k) retirement savings with a company match

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• Clean, and well-lit production areas

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

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