Technical Manager

All applications to come through Alan Kane at Kleboe Jardine - [email protected]

We are currently hiring for a Technical Manager position here on a permanent basis.

As Technical Manager you will bring a combination of hands-on engineering and scientific development expertise, including manufacturing knowledge to the company, helping FMS to deliver effective solutions, from concept through to commercialisation, for our customers.

You will have responsibility for a number of customer projects or products, acting as a primary liaison between clients and our in-house team. Responsible for a team of technical staff (manufacturing and/or engineering), depending on business requirements, you will provide technical direction and guidance on projects under development, and product lines produced for commercial sale. You will work collaboratively with cross functional colleagues to achieve customer outcomes.

Essentially, you will own all aspects of the project and products ensuring sound technical and manufacturability solutions are developed and implemented and that the product or service meets client expectations.

This is a cross functional role and as such you will be expected to orchestrate development and operational activity, comfortably moving between functions as required.

Key Responsibilities

General focus:

• Managing several client projects or products simultaneously
• Representing the company as a primary client contact
• Interpreting customer requirements and in turn generating technical specifications and associated documents to achieve product realisation
• Authoring, overseeing, and executing protocols
• Working with technicians to produce product and process technical documents to successfully introduce new products into manufacturing.
• Establishing manufacturing processes that cost effectively deliver quality product
• Evolve technical capability of the organization through continued learning and championing current best practices.
• Communicating effectively with sub-contractors and suppliers.
• Establish effective KPIs (leading and lagging indicators) and use to monitor departmental health and leverage for continued improvement.
• Process flow development with key attention to effect on capacity and costs.
• Recruitment of suitable personnel, ensuring new team members add technical muscle to the organisation.

Development focus:

• Own the design and development process for allocated projects and ensure that all quality and regulatory procedures are adhered to.
• Designing and developing solutions to complex challenges, quickly and robustly.
• Managing a team of cross discipline product developers, and directing and supporting other colleagues as and when required.
• Establish and manage effective communications with clients.
• Develop products/processes/components in line with client needs, ensuring design inputs are met, and products are manufacturable, cost effective, safe, and reliable.
• Manage Project timelines for internal and external communications, managing all associated challenges.
• Establish effective KPIs (leading and lagging indicators) and use to monitor departmental health and leverage for continued improvement.

Knowledge, Skills & Experience

Essential

• A minimum of degree level qualification in a relevant technical subject (consideration will be given to candidates without qualification where substantial related experience is demonstrated)
• Significant experience in a similar role
• IVD product development manufacturing experience
• Competent in the use of modern manufacturing equipment (e.g. Potentiostats, lab analysers, spectrophotometers, fluorimeters)
• Understand Design for Manufacture (DFM) methodology
• Understand reagent design and preparation processes
• Competent to perform statistical analysis on data using tools such as Minitab
• Good communicator (both written and verbal)
• Excellent time management skills, with track record of successful management of multiple projects to tight timescales
• Project Management skills
• Understanding of Lean and Six Sigma tools and techniques or equivalent.
• Effective people manager, able to develop your team.
• Experienced working within ISO 13485 or 21 CFR Part 820 regulations

Desirable

• Knowledgeable in use of 2D and 3D CAD software such as Draftsight and Solidworks
• Electrode design for biosensors capable of maximising performance while aligning with DfM principles.
• Microfluidic design for biosensors capable of maximising performance while aligning with DfM principles.
• Reagent design for biosensors capable of maximising performance while aligning with DfM principles.
• Development of novel biosensor from the ground up, rapidly resolving challenges as they arise.
• Development of mathematical models and algorithms capable of translating raw data into end user results.
• Competent in the use of MS project
• Familiarity with product and process validation
• An understanding of GxP (Good Manufacturing Practices Good Lab practice) and Quality Management Systems.
• Black or Green belt qualification in six sigma / process excellence.

Visa Sponsorship is available for candidates with the right skills.

Apply above or reach out to me at [email protected] for a confidential discussion about the opportunity