Job Description :Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers. We are looking for a Manufacturing Engineer II to join our team. As a uniquely qualified candidate, you will be responsible for production planning and inventory control for multiple products while prioritizing operations to ensure maximum performance and minimum delay. This individual will take a lead role in continuous improvement, product flow and capacity improvement to improve the overall efficiency of manufacturing while service level targets. SUMMARY: Works on problems and projects where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action in order to develop, implement and sustain production processing methods and control to meet company standards. Participates in decisions within the scope of work. May provide technical guidance to lower level personnel. Will work with operations and quality teamsESSENTIAL DUTIES AND RESPONSABILITIES include the following. (Other duties may be assigned.ESSENTIAL DUTIES AND RESPONSABILITIES Responsible for ensuring personal and company compliance with local and company regulations, policies and procedures for Health, Safety and Environmental compliance.Properly document activities in accordance with the best engineering practices, company procedures, and regulatory requirements (technical reports).Work with R&D/Design/Development/Transfer Engineers or Customers to understand the products to be produced.Able to conduct basic to complex quality visual inspection of parts in accordance with process or other control procedures such as Work Standards.Responsible for cost effective manufacturing product/lines through the management of yield, material usage (BOM and consumables).Conducts engineering efforts to identify root cause analysis.Responsible for the development and implementation of standard manufacturing methods, process and efficiency improvements.Conducts engineering efforts to optimize medical component processing for manufacturing (time studies, working standards, process flows, etc).Conducts and documents time studies to establish performance standards.Executes cost analysis (material, labor and burden) as required.Analyzes and implements improvements to reduce product costs.Designs layouts for production lines.Responsible for design/development of equipment, tools or fixtures that meets health, safety and environmental standards set by the company for manufacturing methods.Setups and validates production lines for manufacturing as applicable.Lead product transfers, and new product introductionsBuilds business relationship with customer and/or suppliers.Investigate, respond and solve quality issues, or provides supports for that process as required.EDUCATION and/or EXPERIENCE: Bachelor´s degree in engineering, with 2-3 years of experience. Experience in the medical device industry would be an asset. Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheet, graphics and statistics.Qualifications in statistics, materials and Mechanical knowledge will be a plus.SKILLS AND COMPETENCES Knowledge on Quality and Medical Regulations (focus Process Validation, traceability, manage or quality issues, risk management)Technical skills in manufacturing processes and methods including tooling, work flow, layout, assembly and production equipment.Is able to become a SME and is able to train others.OPEX - Basic Quality Tools: 5S, Kaizen, Pareto, Ishikawa, Control Charts, Checklist, HistogramsConduct meetings in a structure manner.Provides updates in a structure manner.Ability to work under pressureAnalytical skillsMentoringTeamworkAccountabilityAbility to organize and manage multiple tasks and prioritize.Attention to detail.Recognize a problem and propose solutions.Excellent interpersonal and communication skills.Strong team player, self motivated.Excellent problem solving skills.COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.
