Manufacturing Engineer I

Summary

The Manufacturing Engineer I assists in developing, implementing. and improving new and existing manufacturing processes for medical device production. Provides engineering support to new product and process instructions, ensuring that all activities are completed and documented in accordance with company procedures. Support current production, providing technical solutions to meet quality, safety, cost, and efficiency goals. Supports Continuous Improvement initiatives. The Manufacturing Engineer I will be assigned to either the New Product Introduction group or the Sustaining Engineering group as required, while also supporting projects related tot he greater team and company effort.

Essential Job Functions

• May participate in multifunctional teams, led by a Program Manager and is responsible for defined project deliverables.
• May support the estimating process by providing materials and labor estimates for quotations.
• Assists in developing and maintaining manufacturing documentation for products, to include ERP system setup, Component Drawing and Specifications, Inspector Plans, bill of Material and Routing, Assembly and Packaging Drawings, Standard Operating Procedures (SOP's), Work Instructions, Quality Plans, and other required documents. ensures that all documentation is generated in compliance with company quality system procedures and customer requirements.
• Assists in implementing changes to products through the ECO process.
• Assists in supplier selection and equipment validations, including IQ, OQ & PQ and Test method Validation (TMV). Reviews results with Sr. Engineer or Group Leader.
• Supports process flow, assembly line layout, assembly work standards, and designing of fixtures to ensure high quality and repeatable production of parts.
• Participates in Process Failure Modes and Effects Analysis (PFMEA) for products.
• Supports Operations Department by providing solutions to production issues, with guidance from Sr, Engineer or Supervisor. May provide training or work direction to operators.
• Prioritizes the resolution of customer issues, changes or requests.
• Supports investigation on part nonconformities, customer complaints & corrective & Preventative Action (CAPA).
• May participate in improvement projects in support of Operational Excellence program.
• Set goals, plan and organize tasks to complete in a timely manner, with close direction from Senior Engineer or Supervisor. Regularly reports status to supervisor.
• Recognizes and adheres to job procedures, GMP and safety procedures.
• Keeps abreast of new/developing technologies and trends within medical device manufacturing.
• May include other duties as defined by the department manager.
  
  

Knowledge And Education

• Bachelor's Degree in Engineering (Manufacturing, Industrial, or Mechanical Engineering)
• Engineer in Training (EIT) Certification
• Certified Lean Six Sigma Green Belt and able to demonstrate an understanding of its principles
• Knowledgeable of ISO 13485, GMP and FDA as it applies to medical devices
• Proficient with ERP systems and ECO process
  
  

Skills & Competencies

• Exudes values of being customer-centric, accountable, collaborative, respectful, and demonstrates active listening.
• Driven, with a sense of urgency. Self-motivated, with a strong desire to learn and improve self.
• Excellent attention to detail and accuracy. Establishes and maintains high standards of quality and considers excellence a fundamental priority.
• Understands how to apply modern principles of productivity and project management to plan and achieve goals.
• Good command of the spoken and written English language. Ability to summarize assignment status to supervisor in verbal or written form. Demonstrates techniques of good documentation.
• Strong analytical, technical and troubleshooting skills. Hands-on approach to problem solving.
• Working knowledge of modern manufacturing principles and methods.
• Working knowledge of Lean Six Sigma principles.
• Working knowledge of ERP systems and ECO processes.
• Working knowledge of IQ, OQ, PQ Validation Methodology and statistical techniques.
• Basic understanding of GMP, ISO 13485 and ISO 14971.
• Working knowledge of Quality tools such as 'Define, Measure, Analyze, Improve, Control' (DMAIC), 'Failure Modes & Effects Analysis' (FMEA), 'Design of Experiments' (DOE), 'Gage Repeatability & Reproducibility' (Gage R&R), and 'Statistical Process Control' (SPC) as required.
• Working knowledge of AutoCAD and SolidWorks, with the ability to create 2D drawings, manipulate 3D assemblies and moder moderately complex fixtures and gages.
• Working knowledge of Microsoft Outlook, Microsoft Project, Microsoft Visio, and Microsoft Office applications.
  
  

Physical Requirements

• Light physical activity performing non-strenuous, day-to-day activities of a primarily administrative nature.
• Moderate lifting (20 lbs.), carrying (10 lbs.), bending, and prolonged sitting.
• Requires the ability to identify and distinguish colors.
• Requires the ability to judge distance and space relationships (i.e. visualize objects of multiple dimensions).
• Well-lit, air-conditioned, indoor laboratory and production settings with adequate ventilation.
  
  

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

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