Manufacturing Engineer II
Develops, implements, and improves new and existing manufacturing processes for medical device products. Provides engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with company’s procedures. Supports current production, providing technical solutions to meet quality, safety, cost, and efficiency goals. Supports Continuous Improvement initiatives. Position will be assigned either to the New Product Introduction Group or the Sustaining Engineering Group as required, while also supporting projects related to the greater team and company effort.
- Manufacturing, Industrial, or Mechanical Engineering disciplines preferred
- Previous experience in medium/high volume assembly manufacturing environment
- Previous experience with medical devices
- Engineer in Training (EIT) Certification
- Certified Lean Six Sigma Green Belt
- Bachelor’s Degree in Engineering, with 2-5 years of professional experience in an engineering role
- Previous experience with process development, SolidWorks/AutoCAD, and generating various document types
Handles some complex tasks within the job function. Assists more experienced engineers in large projects and may have primary responsibility for small to medium sized projects. Occasionally directed in several aspects of the work. May provide technical guidance to lower level technical employees. Makes recommendations based upon analysis and reviews with Group Leader or Sr. Engineer.
- Participates in multifunctional teams, led by a Program Manager and is responsible for defined project deliverables.
- May support the development of costing for new products by providing material and labor estimates.
- Develops and maintains manufacturing documentation for products, to include ERP system setup, Component Drawings and Specifications, Inspection Plans, Bill of Material and Routing, Assembly and Packaging Drawings, Standard Operating Procedures (SOPs), Work Instructions, Quality Plans, and other required documents. Ensures that all documentation is generated in compliance with company quality system procedures and customer requirements.
- Implements changes to products through the ECO process.
- Supports supplier selection and sourcing of parts, materials and equipment. Works closely with suppliers to ensure design requirements are adequately defined and met. Creates First Article Inspection (FAI) plans.
- Executes process and equipment validations, including IQ, OQ, & PQ and Test Method Validation (TMV), performs data analysis on results. May assist in the development of protocols and reports.
- Supports process flow, assembly line layout, assembly work standards, and designs 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 performing manufacturing process troubleshooting and practical solutions. Trains or provides work direction to operators. Keeps abreast of operations KPIs.
- May attend customer meetings for assigned products. Prioritizes the resolution of customer issues, changes and requests.
- Performs investigation on part nonconformities, customer complaints & Corrective & Prevention Action (CAPA).
- Identifies and implements improvement projects in support of Operational Excellence program.
- Set goals, plans and organizes own project activities to complete them in a timely manner, while being aware of and sensitive to overall program goals. May assist in planning larger segments of a program. Tracks and reports progress against goals on an ongoing basis.
- Verifies conformance of activities to job procedures, GMP and safety procedures.
- Keeps abreast of new/developing technologies and trends within medical device manufacturing.
SKILLS AND COMPETENCIES
- Exudes values of being customer-centric, accountable, collaborative, and 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 for quality and considers excellence a fundamental priority.
- Strong analytical, technical and troubleshooting skills. Hands-on approach to problem solving.
- Effective at using verbal and written communications skills to present on project status, discuss and present technical topics, and influence decision making on a 1-on-1 basis. Employs proper documentation techniques.
- Applies modern principles of time and project management to plan and achieve goals.
- Demonstrated understanding and application of modern manufacturing principles and methods to a medical device manufacturing operation.
- Demonstrated understanding of Lean Six Sigma principles.
- Proficient with ERP systems and ECO process.
- Demonstrated understanding and application of IQ, OQ, PQ Validation Methodology
- Demonstrated understanding of GMP, ISO 13485, and ISO 14971.
- Demonstrated understanding 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.
- Demonstrated experience with AutoCAD and SolidWorks. Should be capable of developing 2D drawings, manipulating 3D assemblies and modeling moderately complex fixtures and gages.
- Demonstrated proficiency in Microsoft Outlook, Microsoft Project, Microsoft Visio and Microsoft Office applications.
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.
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.