The ME/QE Lead Engineer is a multifunction role working with Operations, delivering on Quality, Engineering and Safety needs. This position will be a pivotal role in ensuring the organization's continued development and growth, whilst ensuring Arcmed is compliant with its own standardized processes and procedures and ensuring regulatory compliance throughout.
* Technical support of machine shop cell focused on efficiency, quality and on time delivery.
* Working closely with Design Engineering on new product development manufacturing requirements and process improvements.
* Support operations in cost reduction by improving efficiencies.
* Challenge the existing process and look to devise and implement an improved version. This will include sharing best practices across facilities.
* Responsible for developing and implementing an understanding for production losses and reducing those unplanned losses in ways that evaluates and resolve their root causes.
* Responsible for development and preparation of process improvements and accountable for leading instruction, facilitating team decisions, managing teamwork, resolving conflict, assisting with implementation, and conducting required follow-up.
* Initiates process improvements through continuous improvement techniques that support quality improvements, cycle time reductions, cost reductions, and other activities aimed at reducing/eliminating non-value-added work.
* Prepare and present Capital Equipment Requests, taking into consideration business strategies and goals, justification for each request and alternative options.
* Complete technical material updates from Product Instructions, Work Instructions and Production drawings.
* Compile and assess Diba Operations team’s continuous improvement plans, driving cross functional teamwork and data-based decision making to solve problems, and develop the future state of Diba operations.
* Key contributor and team member engaged in our manufacturing strategy, analyzing and proposing improvements to our global operations through rationalization of processes and streamlining of material and process flow.
* Ensure Lean Manufacturing Tools and Techniques are deployed in line with our continuous improvement plan, facilitating training as needed to develop a team of change agents in our Operations team.
* Participate and engage in New Product Development discussions with our Sales and Engineering teams, representing the operations team in these discussions to ensure Design for Manufacturability, capacity and capability considerations and made in project/RFQ discussions.
* Ensure design requirements are clearly defined to customers and production team with thorough documentation and tolerancing.
* Provide troubleshooting support for CNC machinists/operators, inspectors, manufacturing engineering and quality.
* Ensure accurate engineering/inspection data for production transfer.
Quality & Safety
* Lead in developing a robust and effective Quality Management System and all supporting documentation, ensuring all processes are relevant and up to date.
* Oversee CAPA, work with Manufacturing, Operations and Engineering to assist with containment, root cause analysis, corrective action, and preventive action. Conduct effectivity checks for CAPAs.
* Return Material Authorizations, supports RMA requests from customers, tracks, and trends RMA data for Management Review, they will assist with RMA investigations as needed and provide feedback to the customer. As well as complaint handling.
* Monitor and measure Key Performance Indicators (KPIs) and present findings during Management Review
* Conduct training to internal procedures.
* Non conformances and Material Review Board (MRB), disposition non conformances, disposition discrepancy material reports, manage MRB process as needed, tracks and trends nonconformance and MRB data.
* Represent Quality in product development teams/projects. Work with various Engineering groups or QA Manager to develop and execute plans including quality plan, risk management, Process Failure Mode and Effects Analysis (PFMEA), control plans, production part approval process (PPAP), part qualification checklist (PQC)
* Lead Supplier Corrective Actions Requests (SCARs) - containment, root cause analysis, corrective action, and preventive action.
* Ability to interpret Geometric Dimensioning and Tolerancing (GD&T)
* Lead Risk Assessments, safety audits and policy/procedure generation for all safety aspects within the business.
* Safety compliance statements such as REACH, RoHS etc.
* Work as directed by manager.
Educational requirements, Qualifications, and Trainings
* Preferred experience in a strong lean manufacturing environment, possessing an ability to engage our team in lean exercises such Kanban Systems Implementation, Visual Management, 5S, Value Stream Mapping, Waste Elimination.
* Lean Six Sigma – Yellow/Green belt is a plus.
* IOSH Managing Safety is a plus.
* 3D modeling experience required (SolidWorks a plus)
* Geometric Dimensioning & Tolerancing
* Operating in a highly regulated industry (Pharma, automotive, aerospace etc.)
* Ability to champion change and effectively manage the implementation of new ideas.
* Knowledge of quality systems and standards
* Ability to learn modern technology in a fast-paced environment
* Excellent ability to communicate orally and in writing in English.
* Well-developed literacy, numeracy and computer skills with a technical aptitude.
* Strong understanding of customer and market dynamics and requirements.
* This position may require travel within the UK, Europe and USA.
* This position is on-site 5 days per week.
Computer and Software Requirements
* Experience with Epicor a plus.
* Knowledge in GD&T tolerancing, how to both read and apply.
* Experience in risk analysis, ability to perform FMEA.
* Knowledge of ISO 9001.
* Knowledge in safety standards.
* Experience in inspection techniques and equipment.
* Ability to plan and perform capability studies and process validation.
* Experience in world class quality improvement techniques (Lean, Six Sigma, etc.)
* Experience in robotics and automation.
* Microsoft: Office 365; SharePoint; Teams; Visio; and OneNote preferred.
* Ability to operate media equipment such as tablets, smartphones, and other electronic equipment.
* Ability to work with general office equipment.
* Ability to work with and understand databases a must and the ability to learn technical skills.
PHYSICAL REQUIREMENTS & WORK ENVIRONMENT
* Shall have essential physical skills; be able to run, squat, stoop/bend, kneel, climb stairs, be able to lift at least 50 pounds (or ¼ own body weight).
* Shall have adequate vision, reading, writing, and documentation skills, and hearing to perform the essential functions of the job.
* Must have enough endurance to perform tasks over long periods of time.
* Will be engaged in speaking, sitting, walking, driving, listening, and in communicating both orally and in writing while performing his or her duties.
* Must be able to listen and respond to questions and instructions.
The qualifications, physical demands, and work environment described herein are representative of those an employee will encounter and must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
The above noted job description is not intended to describe, in detail, the variety of tasks that may be assigned but rather to give the incumbent a general sense of the responsibilities and expectations of his/her position. As the nature of business demands change, so, too, may the essential functions of this position.