Senior Process Engineer

Location

Glasgow, UK

Job Type

Company Overview

LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.

Role & Responsibilities

This role could be based at our site in Alloa OR  Glasgow and travel between both sites might be required.

Role Description

An experienced Senior Process Engineer who can make a significant contribution to the continued growth and success of our company.

As a Senior Process Engineer you will have an excellent understanding of all aspects of the product lifecycle and strong technical / scientific understanding of existing and new assay products. Possess strong networking skills in order to build effective relationships, manage critical projects and correct material issues / non-conformances with external suppliers / technical partners.

Support product and process issues across multiple departments and review and support closure of quality events / non-conformances. Lead and execute validation and verification activities and documentation updates, as well as product and process characterisation activities.

Lead Kaizen events and improves the mapping of processes, control plans and risk assessments to enhance productivity and quality. Supports Equipment and Maintenance Engineers with design and development activities and leads a team of 4 or more engineers to deliver on business related goals.

Key Areas of Responsibility

  • As a Senior Process Engineer you will have excellent understanding of all aspects of the product lifecycle and strong technical / scientific understanding of existing and new assay products
  • Work closely with external suppliers to correct material issues / non-conformances
  • Lead Kaizen events and mentor / train production team on continuous improvement initiatives to deliver manufacturing excellence
  • Supports process / product issues across many departments (e.g. Manufacturing, Calibration, Packaging, Customer Complaints)
  • Develops and improves mapping of processes, control plans and risk assessments to enhance quality and productivity
  • Supports Equipment and Maintenance Engineers in the design and development of new tooling / equipment and / or fixtures
  • Lead a team of 4 or more engineers to deliver on business related goals
  • Review and support closure of quality events / non-conformances
  • Leads process and product characterisation activities and identifies new methods of analysis
  • Leads validation and verification activities, test method development and documentation updates
  • Excellent understanding of scientific assay principles and product release testing / calibration methods
  • Works cross-functionally in order to help deliver business goals (e.g. Product Support, R&D, Supply Chain)
  • Implements new strategies to transform production site into best in class facility (e.g. cost reduction, health and safety, quality culture and work ethos etc.)
  • Support internal audits and ensures highest levels of quality and compliance at all times
  • Continuously review manufacturing documentation for accuracy and make updates using document change control
  • Be open to self-development and training opportunities to enhance professional skillset
  • Investigate, root cause and resolve non-conformances / quality events
  • Good understanding of ISO 13485 and other related regulations
  • Support internal audits when necessary
  • Ensure changes to process and specifications meet quality standards and are documented appropriately
  • Adhere to all relevant quality and regulatory requirements

Required Experience

About You

Essential Skills:

  • Experience of optimising product and processes within industry (preferably medical device)
  • Excellent understanding of scientific assay principles and product release testing / calibration methods
  • Demonstrates excellent problem-solving skills (e.g. thinking critically to make key decisions under pressure)
  • Understanding of lean manufacturing principles and statistical analysis methods/techniques
  • Proficient in use of MS Office, Powerpoint, data analysis software (e.g. Minitab, Excel) and CAD software
  • Comfortable working with external suppliers and cross-functionally to deliver business goals
  • Lead and execute validation and verification activities and ensures timely completion of associated documentation
  • Drives manufacturing excellence through engagement / training of production team on continuous improvement initiatives and quality standards
  • Technical engineering lead for process and product issues and ensures fast and effective closure of quality events / non-conformances
  • Ensures highest standards of quality and compliance maintained at all times
  • Excellent understanding of process and product characterisation methods and CTQs
  • GxP experience
  • Competent in documentation writing and presenting to key stakeholders

Desirable Skills:

  • Process Excellence Green or Black Belt
  • Preferably Degree qualified
  • Experience in rotary converting and / or reel to reel printing (rotary screen / flexographic etc.) additional advantage
  • Understanding of ISO 13485 relating to manufacturing, other regulations and standards would be an advantage.
  • Experience in mentoring / training work colleagues to aid professional development
  • Experience in leading a team of 4 or more engineers to deliver on business goals

At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business

Please note, if you wish to submit an application for this role, please consider the following information

This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.

Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.

LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.

 

For further information and to apply for this role, please click APPLY

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Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security.