Production Engineering Lead
Main Purpose of position
The Production Engineering Lead will be site-based, working primarily within the Production Engineering Team but will have key working relationships with other departments.
This role requires a driven individual that is able to motivate and support members of the Production Engineering team to achieve targets as well as take ownership of customer driven deadlines.
You will work closely with, and provide resource to, the NPI (New Product Introduction) lead to assist with the timely introduction of new products, this shall include work cell set up, creation of all related manufacturing documentation, ERP structuring, building pilot instruments and carrying out efficiency reviews based on lean manufacturing methodology.
You will also work closely with the QA team to generate PFMEA (Process Failure Mode Effects Analysis) and Process Validation documentation in a timely manner, this documentation shall be to a satisfactory standard to pass ISO13485, FDA, MDR audits. You will be required to take ownership of product change requests (PCR) within the Production Engineering department, assign PCRs to members of the Production Engineering team, monitor progress, and offer support, through to completion.
This role will fully support the manufacturing facility to maintain compliancy to all aforementioned regulatory requirements.
- Data Entry on ERP System
- Build pilot production instruments
- Carry out the initial training, and setting up the training log for production staff, prior to handing over to the production supervisor to maintain
- Create and maintain training logs for the production engineering team
- Controlling Software, Firmware and Gerber Files
- Oversee the creation of all manufacturing documentation, carrying out a review, alongside the production team, prior to official production training record creation and sign off
- Provide justification in the form of a work efficiency analysis to present to senior management for review. This shall be for such things as, but not restricted to, new tooling, design of custom fixtures, staff increases, new software, etc.
- Problem-solving in the form of current production process review, as well as documenting CAPA related issues and resolutions
- Assist QA with the generation of DMR (Device Master Record)
- Create and maintain project related GANTT charts for review with senior management, as well as the customer
- PFMEA/Process Validation
- Calculation of labour costs to support the quotation of commissioned technical file maintenance
- Willingness to travel to customer/supplier sites within the UK and internationally
- Carry out route cause analysis
Necessary qualifications and training
- Minimum HNC/HND or equivalent in either mechanical, electronic or manufacturing
- 5+ years of experience in high-tech engineering to exacting standards
- Lean manufacturing experience
- Customer-facing role, so excellent written and communication skills are essential
- Evidence of ability to work with critical attention to detail and high levels of accuracy
- Excellent time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
- Experience of ERP like Syspro or another
- Microsoft Office proficiency, particularly desirable in Excel, macros, pivot tables, etc.
Beneficial but not essential:
- Experience of Microsoft Project
- Experience of ISO 13485
- CAD and Design experience
- Programming in C or Python
- Team management experience
- Use of Silicon Expert
25 days annual leave
8% non-contributory pension
Simply Health medical plan
Cycle to work scheme
Site-based. 39 hours per week. 7.30am – 4.30pm Monday to Thursday, 7.30am – 12.30pm Friday
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