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Project Engineer

Project Engineer

Nissha MedicalNew Richmond, WI, United States
16 hours ago
Job type
  • Full-time
Job description

Founded in 1990 and based in New Richmond, WI, Isometric's vision was to manufacture tooling and provide manufacturing solutions to exacting specifications for ultra-small, ultra-precise, and ultra-complex applications. For the past 35 years, we're proud to say we've grown to be one of the largest medical-focused micro molders in the United States. In March 2024, Isometric was acquired by Nissha Medical Technologies (NMT) , a global Contract Design / Development Manufacturing Organization. NMT's expertise in the design and development of endoscopic devices, combined with Isometric's micro-molding capabilities, have the potential to redefine the realm of minimally invasive surgical instruments and surgical robotics. Together, we aim to address the changing demands of medical devices by enhancing component miniaturization and improving the maneuverability of small and precision components, ultimately advancing medical efficiency.

It's an exciting time to join our team, and we're hiring for a Project Engineer . This role is responsible for managing assigned customer projects through process development, validation, and production while upholding Isometric's core competencies and continuous improvement. The hours for this position are Monday-Friday, 7 : 00AM-4 : 00PM.

Essential Functions and Responsibilities :

  • Ensure the Project Engineering team projects are entered and consistently maintained in Epicor to support interaction with all departments and month end T&M billing
  • Ensure all project costs are properly captured and within customer's PO scope and Isometric's quoted margins, this includes cycle times, shot size, scrap, resin cost and MOQ's, inserts, packaging, inspection, trimming, assembly, and all other costs. Alert and provide Sales cost information when differences occur.
  • Support forecasting, equipment utilization, and capacity planning
  • Responds to customer within 24 hours and provides proactive customer follow-up
  • Provides timely and clear communication to customers and cross-functional internal team members
  • Creates project timelines and successfully achieves and meets deadlines and commitments
  • Serve as customer point-of-contact for assigned projects
  • Create and implement solutions that meet customer expectations
  • Lead assigned injection molding projects through process development, validation, and production
  • In collaboration with the Development Engineering group, establish redlines from customer supplied data for assigned project mold design & builds
  • Collaborate with Development and Automation teams to determine best manufacturing approaches for projects requiring automation
  • Ensure all changes in project scopes are managed and costs controlled
  • Identify and monitor overall program costs, timing, and deliverables to ensure key milestones are achieved
  • Determines costs including 3rd parties, secondary operations, labor content, scrap, cycle time input, shot size per part with runner and sprue to Sales for quoting, as needed
  • Collaborate with cross-functional team members to schedule resources required for timely execution
  • Oversee assigned project validations through protocol development, installation qualification (IQ), initial testing, troubleshooting, process development, operational qualification (OQ), and production qualification (PQ)
  • Develop DOE's, FMEA's, Production Documentation, and Control Plans
  • Work with Quality to establish inspection methods
  • Comply to the requirements of ISO9001, ISO13485, and ITAR as required
  • Ongoing support of production throughout entire life cycle of product
  • Reviews and understands ISO13485 standards of Quality and Continuous Improvement
  • Manage and perform ECO process on assigned projects
  • Establish preventive maintenance procedures to safeguard equipment and the quality of manufactured product
  • Trouble-shoot and solve production manufacturing issues
  • Collaborate with sales team to determine pricing and delivery for project deliverables
  • Demonstrate Isometric Core Competencies and Continuous Improvement
  • Travel to customer facilities, tradeshows, and other events as required
  • Other duties as assigned

Education and / or Experience :

  • Bachelor's degree in Engineering with the following directly related experience :
  • Minimum (3) years applied engineering experience
  • Minimum (3) years of demonstrated project management experience
  • Minimum (3) years of demonstrated validation experience
  • Broad knowledge of resin and other materials
  • Broad knowledge of precision manufacturing
  • Experience in injection molding
  • Experience in injection mold tooling
  • Experience with 3D CAD software and understanding of how injection mold tooling is designed
  • Experience with reading and understanding part drawings
  • Demonstrated knowledge of interpreting metrology and physical testing data
  • Medical device and / or Pharma industry experience highly preferred
  • Understanding of ISO13485 and its requirements
  • Understanding and analysis of Design of Experiments (DOE)
  • High level of integrity and ethics that aligns with Isometric Core Values
  • Ability to travel
  • Isometric offers a comprehensive benefit package along with competitive pay :

  • 401(k) program with Company match available after 90 days
  • 3 weeks of paid time off, 2 personal days, and 11 paid holidays (10 observed holidays + 1 floating holiday of your choice)
  • Medical, Dental, and Vision options available the 1st of the month following your date of hire
  • Health Savings Account options available including a quarterly company contribution
  • Company paid coverages include Employee Life / AD&D & Short Term Disability
  • Voluntary benefit options include Long-Term Disability, Supplemental Life / AD&D for Employees, Spouse, and Children, Group Accident Insurance, Home Warranty coverage, Legal support coverage, and Pet Insurance!
  • Hands on training
  • Isometric, a NMT Company, is an Equal Opportunity employer. We are committed to creating a diverse workforce; we support a work environment where colleagues are respected and given the opportunity to perform to their fullest potential. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability or veteran status, among other factors.

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