Group Lead - Instrument Hardware Engineering

at  Nuclera

Nuclera is a venture-backed, founder-driven biotech company headquartered in Cambridge, UK with significant operations in Boston, USA. The company’s mission is to improve human health by making proteins accessible. We are beginning this mission through the launch of our eProtein Discovery™ platform. eProtein Discovery is a breakthrough protein expression, characterization, and purification technology, consisting of a lab-based benchtop instrument, cloud-based software and proprietary cartridges and consumables. The goal is to enable rapid protein access to life science researchers around the world.

Reporting to the AVP of Instrument development, leading a multi-disciplinary engineering team, you will support commercial growth by:

• Being responsible for all hardware engineering aspects of Instrument development;
• Delivering new Instrument-based solutions to market;
• Enhancing existing Instrument hardware solutions;
• Supporting Instrument manufacture and service;
• Nurturing innovation.

Instrument Design & Development – Whole life-cycle development of prototypes and commercial products, including:

• Requirements management
• Specification definition.
• Instrument Architecture design / definition of critical system interfaces.
• System Risk Management – Management of hazards and risk control measures.
• Using multiple technologies to control motion, fluidics, imaging, operating conditions.
• Simulation / multi-physics modelling.
• Design for prevention / management of contamination.
• Design of packaging and labelling to satisfy needs of global third-party logistics.
• Design For Manufacture & Assembly.
• Value engineering / Product cost management.

Technical Disciplines – Required competencies:

• Mechanical Engineering – Subject Matter Expert
• Optical Engineering / Electrical & Electronic Engineering – Able to understand and manage the work of senior level technical specialists / consultants.

Design Quality Assurance – Lead review, simulation, experimentation and testing of various kinds to ensure fitness for intended use, to include:

• System, sub-system, component level testing.
• Fluidic and in-vitro biological performance.
• Independent review / testing of Cartridge designs.
• Reliability modelling and testing.
• Type approval – Functional safety & EMC.

Instrument Manufacture & Service – Support volume manufacturing solutions, including:

• Design Transfer / Product Data Management using PDM and ERP systems.
• Design, deployment and improvement of production processes.
• Design and provision of manufacturing support tools.
• Authoring / review of build manuals and quality control procedures.
• Support supplier selection and evaluation.

Line Management – Responsible for multidisciplinary engineering team, to include:

• Recruitment / On-Boarding
• Appraisal / Performance Management
• Training / Professional Development

Key Relationships - Establish and maintain effective relationships in the following areas:

• Cartridge development and manufacture
• Workflow development
• Production / Logistics
• Product management
• Engineers, bioengineers, scientists and technicians in other disciplines.
• External development partners and production suppliers.

Processes – Define and implement design and development processes, sufficient to ensure the required safety, quality and regulatory compliance in all markets served.
Infrastructure – Selection, configuration and management of an appropriate collection of tools to support the full design and development lifecycle.

Quality Management – Designs to be developed in a defined manner to required standards:

• Quality Management System – Compliance with the company’s quality procedures. Define / revise Standard Operating Procedures and Work Instructions.
• Documentation – Ensure all development is documented to necessary standards. Provide material as required to support regulatory submissions (e.g. Technical Files). Support review of other relevant documentation provided by others.
• Regulations & Standards – Ensure that all development complies with requirements of external regulations and standards.
• Design Assurance – Use of appropriate means to ensure that designs comply with requirements and satisfy necessary standards.
• Issue / CAPA Management – Provide an effective means by which issues occurring in development, or the field, will be recorded and appropriately managed.
• Change & Configuration Control – Manage change to ensure that all product configurations are properly managed through development and use in the field.
• Auditing – Act as a company representative in quality audits.