Process Engineering Manager
hace 20 horas
Winsford
Process Engineering Manager - Start date from 5th January 2026 Who are Advanced Medical Solutions? AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see ___ AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law. Job details: • Leadership of Process Engineers to enable AMS performance and growth., • Responsibility as Site Leadership Team member, contribute to site leadership meetings, strategy development and driving group purpose, mission and values., • Provide technical direction and leadership., • Manage team and project communications., • Recruit, hire, evaluate, review, and retain high performing personnel., • Working on prioritisation driven from the business, identify and scope the required work. Organize and build detailed plans including schedules, resource budgets, quality and risk management plans, and verification and validation plans. Prioritize work and organize timely responses to urgent situations., • Leading the team and managing costs associated with it., • As a core member of the site leadership team, make yourself available to support other operational teams as required., • Enable improvement to manufacturing process via capability enhancement, process development and capital investment., • Enable right first time NPD product development for Operations by driving design for manufacture and process capability expectations through the design transfer process., • Performance management of individuals to ensure business objectives achieved consistently & competency issues dealt with proactively., • Development of process engineering personnel to continue to raise levels of skill, capability and professional competence., • Continually improve Process Engineering reputation and impact by proactively working with internal and external customers to increase team’s focus on needs, including support to the Commercial team due to production issues., • Implement functional strategy to place long term plan on Process Engineering improvement & AMS performance improvement., • Own and coordinate all pFMEA updates for product risk management., • Lead continuous improvement projects to support improvement in OEE and material variance. KEY RESULTS • Leadership of Process Engineers to enable AMS performance and growth, Responsibility as Site Leadership Team member, contribute to site leadership meetings, strategy development and driving group purpose, mission and values., • Positive influence on sales growth by reduction of existing Operational constraints to sales, as well as driving NPD and new opportunities., • Support site validations as required and ensure projects are executed following a structured approach and are delivered on time and within budget., • Development of strong process engineering and validation protocols capturing industry best practise and utilising strong statistical techniques., • Introduction of new equipment and products driven by a focus on consistent and repeatable processes parameters., • Timely resolution of identified deviations and implementation of effective actions to correct and prevent recurrence., • Effective training delivered to the process engineering team to ensure relevant competency is established & maintained., • Documented standard processes exist for all processes within your area of responsibility and objectives are met (Safety, Quality, Cost, Delivery) when standard processes are followed., • Demonstrated delivery of continuous improvement on processes., • Changes / improvements to existing processes, introduction of new processes, new equipment and new products are implemented & transferred to manufacturing in a controlled manner., • Develop team to remove single points of failure in all Processability., • Annual demonstrated improvements in OEE and material variance, through a targeted approach. What will this role involve? In close collaboration with Manufacturing, Quality R&D and Group Engineering, support assigned capital expenditure projects to improve existing manufacturing processes, including: • Development of technical requirements for new processes / new equipment (URS), • Preparation and documentation of capital expenditure requests with supporting business case documentation., • Selection of suppliers for optimal cost / quality based on detailed quotations linked to technical requirements documented., • Assessment and resolution of issues linked to process capability, automation and up-scaling processes from development to commercial production., • Plan & execute validation activities whilst documenting process and product activities in line with agreed cross-functional responsibilities., • Development of new standard processes manufacturing supported with initial procedures, training and coaching of manufacturing staff., • Introduction of Industrialised products focused on long term repeatability and sustainability., • Preparation and review of documents within the validation life cycle including URS, FAT, SAT. Collaboration with site validation to develop and execute IQ, OQ, PQ. Ensuring work is completed in compliance with BSI, FDA and all other regulatory agency standards., • Investigate and resolve issues related to the technical performance or the workability of the manufacturing processes closely working with production and quality and following all applicable procedures (change control, CAPA, validation, procedures, training)., • In collaboration with site validation, deliver the ongoing programme of machine and process validations in line with agreed timescales and in compliance with the relevant medical device regulations., • Ensure that Process Engineering personnel are fully competent to deliver the validation programme., • Ensure ISO standard validation compliance for projects., • Support in the preparation for internal and external audits., • Ensure an appropriate Operations Core Team Member is representing the Operations function for all NPD and new opportunity projects., • Work effectively with other AMS departments/sites as well as external suppliers., • Develop & achieve functional strategy based on ways of working and enablement of industrialisation projects., • Provide support to production as required to ensure continuity of production., • Responsibility as Site Leadership Team member, contribute to site leadership meetings, strategy development and driving group purpose, mission and values. Knowledge & Skills • BS or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 4+ years’ experience in medical device or pharmaceutical industries., • Demonstrate leadership experience in previous roles., • Must be proficient in the knowledge of applicable Quality Regulations and ISO quality requirements., • Knowledge of the Medical Device regulation., • Proficient in knowledge of Manufacturing, Engineering, Validation, Change Control, and Design Control processes., • Proficient in concepts of statistics, sampling plans and statistical analysis., • Proficient in analytical methods, equipment, process, software, cleaning and/or facility/utility validations., • Ability to independently plan, execute, and/or problem solve moderate to complex situations., • Ability to manage multiple complex project timelines and prioritise in response to changing demands., • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions., • Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation., • Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively.