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 Senior Staff 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 of moderate scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Demonstrates full use and application of standard principles, theories, concepts and techniques. Selects design direction or modifications of components of systems. Participates in decisions on scope of work, selection of equipment and length of task. Decides on design changes to meet revised specifications. Provides and develops solutions to problems of limited scope. Must be able to accomplish broad and complex assignments. May provide technical guidance to lower level personnel.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.ESSENTIAL DUTIES AND RESPONSIBILITIES:Ensure personal and company compliance with local and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.Properly document activities according to best engineering practices, company procedures, and regulatory requirements (technical reports).Collaborate with R&D/Design/Development/Transfer Engineers or Customers to understand the products to be produced.Conduct basic to complex quality visual inspection of parts in line with process or other control procedures such as Work Standards.Manage yield and material usage (BOM and consumables) to achieve cost-effective manufacturing products/lines.Perform root cause analysis engineering efforts.Develop and implement standard manufacturing methods, processes, and efficiency improvements.Optimize medical component processing for manufacturing through engineering efforts like time studies, working standards, process flows, etc.Conduct and document time studies to establish performance standards.Execute cost analysis (material, labor, and burden) as required and implement improvements to reduce product costs.Develop, implement, and monitor manufacturing process controls and machinery modifications (re-engineering).Design layouts for production lines.Independently handle most assignments with instructions regarding the expected general results.Design/develop equipment, tools, or fixtures that meet health, safety, and environmental standards set by the company for manufacturing methods.Participate in and approve design reviews and pre-validation assessments to ensure safe and environmentally sound start-up of new processes.Set up and validate production lines for manufacturing as applicable.Lead product transfers and new product introductions.Provide technical supervision and coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.Build business relationships with customers and/or suppliers.Investigate, respond to, and solve quality issues or provide support for that process as required.EDUCATION and/or EXPERIENCE:Bachelor's degree in engineering, with 6-7 years of industry relevant experience.Advanced english skills.Experience in the medical device industry would be an asset.Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheet and graphics.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, workflow, 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, Histograms OPEX -Advance Quality Tools: Methodologies, Green Belt or upper. Conduct meetings in a structure manner.Provides updates in a structure manner.Ability to work under pressure. Ability to work with little supervision. Analytical skills. Leadership. Mentoring. Business visioning (able to see the big picture)Teamwork. Accountability. Ability 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.Supervisory skills and experience desired.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.
