Overview
Join Waters Advanced Diagnostics and help shape the future of clinical diagnostics. As Project Manager, Clinical Software, you will lead the coordination of complex IVD development programmes, bringing together diverse teams to deliver innovative LC-MS diagnostic solutions that meet the highest standards of quality, regulatory compliance, and commercial success. This is an exciting opportunity to contribute to products that have a meaningful impact on patient care while developing your project management expertise within a fast-paced, highly collaborative environment.Join Waters Advanced Diagnostics and help shape the future of clinical diagnostics. As Project Manager, Clinical Software, you will lead the coordination of complex IVD development programmes, bringing together diverse teams to deliver innovative LC-MS diagnostic solutions that meet the highest standards of quality, regulatory compliance, and commercial success. This is an exciting opportunity to contribute to products that have a meaningful impact on patient care while developing your project management expertise within a fast-paced, highly collaborative environment.Join Waters Advanced Diagnostics and help shape the future of clinical diagnostics. As Project Manager, Clinical Software, you will lead the coordination of complex IVD development programmes, bringing together diverse teams to deliver innovative LC-MS diagnostic solutions that meet the highest standards of quality, regulatory compliance, and commercial success. This is an exciting opportunity to contribute to products that have a meaningful impact on patient care while developing your project management expertise within a fast-paced, highly collaborative environment.Join Waters Advanced Diagnostics and help shape the future of clinical diagnostics.Join Waters Advanced Diagnostics and help shape the future of clinical diagnostics.As Project Manager, Clinical Software, you will lead the coordination of complex IVD development programmes, bringing together diverse teams to deliver innovative LC-MS diagnostic solutions that meet the highest standards of quality, regulatory compliance, and commercial success.As Project Manager, Clinical Software, you will lead the coordination of complex IVD development programmes, bringing together diverse teams to deliver innovative LC-MS diagnostic solutions that meet the highest standards of quality, regulatory compliance, and commercial success.This is an exciting opportunity to contribute to products that have a meaningful impact on patient care while developing your project management expertise within a fast-paced, highly collaborative environment.This is an exciting opportunity to contribute to products that have a meaningful impact on patient care while developing your project management expertise within a fast-paced, highly collaborative environment.
Responsibilities
Project Leadership Support the end-to-end IVD product development project workstreams (Software)Assist cross-functional teams to define and project scope, timelines, milestones, and deliverablesWork with the program and principal project managers to ensure workstreams are linked to the overall program goals.Develop and maintain integrated project plans and risk link up with risk management approach.Manage project execution to meet cost, schedule, and performance targetsCross-Functional Coordination Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and MarketingCoordinate meetings, actions, and follow-ups across project teamsSupport clear communication of project updates and statusRegulatory & Compliance Ensure projects comply with global regulatory requirements (IVDR, FDA 510(k), CE marking)Support design control processes (Design History File, risk management, validation)Partner with regulatory teams for submissions and approvalsRisk & Issue Management Identify and track project risks, issues, and dependenciesSupport development and monitoring of mitigation actionsEscalate risks to senior project or programme managers as neededFinancial & Resource Management Support the management of project budgets, forecasting, and resource allocationTrack and optimize project costsEnsure efficient utilization of team resourcesVendor & Partner Management Support the management of external partners, CROs, and suppliersSupport the management of contracts, deliverables, and performanceContinuous Improvement Follow established project management processes and toolsContribute to improvements in PM practices and toolsDemonstrate willingness to learn and develop PM capabilityProject Leadership Support the end-to-end IVD product development project workstreams (Software)Assist cross-functional teams to define and project scope, timelines, milestones, and deliverablesWork with the program and principal project managers to ensure workstreams are linked to the overall program goals.Develop and maintain integrated project plans and risk link up with risk management approach.Manage project execution to meet cost, schedule, and performance targetsCross-Functional Coordination Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and MarketingCoordinate meetings, actions, and follow-ups across project teamsSupport clear communication of project updates and statusRegulatory & Compliance Ensure projects comply with global regulatory requirements (IVDR, FDA 510(k), CE marking)Support design control processes (Design History File, risk management, validation)Partner with regulatory teams for submissions and approvalsRisk & Issue Management Identify and track project risks, issues, and dependenciesSupport development and monitoring of mitigation actionsEscalate risks to senior project or programme managers as neededFinancial & Resource Management Support the management of project budgets, forecasting, and resource allocationTrack and optimize project costsEnsure efficient utilization of team resourcesVendor & Partner Management Support the management of external partners, CROs, and suppliersSupport the management of contracts, deliverables, and performanceContinuous Improvement Follow established project management processes and toolsContribute to improvements in PM practices and toolsDemonstrate willingness to learn and develop PM capabilityProject Leadership Support the end-to-end IVD product development project workstreams (Software)Assist cross-functional teams to define and project scope, timelines, milestones, and deliverablesWork with the program and principal project managers to ensure workstreams are linked to the overall program goals.Develop and maintain integrated project plans and risk link up with risk management approach.Manage project execution to meet cost, schedule, and performance targetsCross-Functional Coordination Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and MarketingCoordinate meetings, actions, and follow-ups across project teamsSupport clear communication of project updates and statusRegulatory & Compliance Ensure projects comply with global regulatory requirements (IVDR, FDA 510(k), CE marking)Support design control processes (Design History File, risk management, validation)Partner with regulatory teams for submissions and approvalsRisk & Issue Management Identify and track project risks, issues, and dependenciesSupport development and monitoring of mitigation actionsEscalate risks to senior project or programme managers as neededFinancial & Resource Management Support the management of project budgets, forecasting, and resource allocationTrack and optimize project costsEnsure efficient utilization of team resourcesVendor & Partner Management Support the management of external partners, CROs, and suppliersSupport the management of contracts, deliverables, and performanceContinuous Improvement Follow established project management processes and toolsContribute to improvements in PM practices and toolsDemonstrate willingness to learn and develop PM capability
Project Leadership
Project Leadership
Project Leadership- Support the end-to-end IVD product development project workstreams (Software)
Support the end-to-end IVD product development project workstreams (Software)
- Assist cross-functional teams to define and project scope, timelines, milestones, and deliverables
Assist cross-functional teams to define and project scope, timelines, milestones, and deliverables
- Work with the program and principal project managers to ensure workstreams are linked to the overall program goals.
Work with the program and principal project managers to ensure workstreams are linked to the overall program goals.
- Develop and maintain integrated project plans and risk link up with risk management approach.
Develop and maintain integrated project plans and risk link up with risk management approach.
- Manage project execution to meet cost, schedule, and performance targets
Manage project execution to meet cost, schedule, and performance targets
Cross-Functional Coordination
Cross-Functional Coordination
Cross-Functional Coordination- Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and Marketing
Collaborate with R&D, Clinical, Regulatory Affairs, Quality, Supply Chain, and Marketing
- Coordinate meetings, actions, and follow-ups across project teams
Coordinate meetings, actions, and follow-ups across project teams
- Support clear communication of project updates and status
Support clear communication of project updates and status
Regulatory & Compliance
Regulatory & Compliance
Regulatory & Compliance- Ensure projects comply with global regulatory requirements (IVDR, FDA 510(k), CE marking)
Ensure projects comply with global regulatory requirements (IVDR, FDA 510(k), CE marking)
- Support design control processes (Design History File, risk management, validation)
Support design control processes (Design History File, risk management, validation)
- Partner with regulatory teams for submissions and approvals
Partner with regulatory teams for submissions and approvals
Risk & Issue Management
Risk & Issue Management
Risk & Issue Management- Identify and track project risks, issues, and dependencies
Identify and track project risks, issues, and dependencies
- Support development and monitoring of mitigation actions
Support development and monitoring of mitigation actions
- Escalate risks to senior project or programme managers as needed
Escalate risks to senior project or programme managers as needed
Financial & Resource Management
Financial & Resource Management
Financial & Resource Management- Support the management of project budgets, forecasting, and resource allocation
Support the management of project budgets, forecasting, and resource allocation
- Track and optimize project costs
Track and optimize project costs
- Ensure efficient utilization of team resources
Ensure efficient utilization of team resources
Vendor & Partner Management
Vendor & Partner Management
Vendor & Partner Management- Support the management of external partners, CROs, and suppliers
Support the management of external partners, CROs, and suppliers
- Support the management of contracts, deliverables, and performance
Support the management of contracts, deliverables, and performance
Continuous Improvement
Continuous Improvement
Continuous Improvement- Follow established project management processes and tools
Follow established project management processes and tools
- Contribute to improvements in PM practices and tools
Contribute to improvements in PM practices and tools
- Demonstrate willingness to learn and develop PM capability
Demonstrate willingness to learn and develop PM capability
Qualifications
Education:Bachelor’s degree in Life Sciences, Engineering, or related fieldProject Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable.Experience:Self-starting, growth mindset with the ability work independently and as part of a team. Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc across organisation. Understanding of the IVD product life-cycle n particular how thois relates to software.Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively.Experince of managing software developmnet [rject in the life science industry. Competencies:2-3 years of project management experience in IVD or life science related industryWillingness to learn and develop in a complex regulated environment. Experience of project management tools and methodologies (waterfall, agile, MS project, Smartsheet’s)Good attention to detail. Basic understanding of a product development lifecycle. Travel (If Applicable):20% to Waters sites and colaborators. In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.Education:Bachelor’s degree in Life Sciences, Engineering, or related fieldProject Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable.Experience:Self-starting, growth mindset with the ability work independently and as part of a team. Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc across organisation. Understanding of the IVD product life-cycle n particular how thois relates to software.Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively.Experince of managing software developmnet [rject in the life science industry. Competencies:2-3 years of project management experience in IVD or life science related industryWillingness to learn and develop in a complex regulated environment. Experience of project management tools and methodologies (waterfall, agile, MS project, Smartsheet’s)Good attention to detail. Basic understanding of a product development lifecycle. Travel (If Applicable):20% to Waters sites and colaborators. In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.Education:Bachelor’s degree in Life Sciences, Engineering, or related fieldProject Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable.Experience:Self-starting, growth mindset with the ability work independently and as part of a team. Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc across organisation. Understanding of the IVD product life-cycle n particular how thois relates to software.Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively.Experince of managing software developmnet [rject in the life science industry. Competencies:2-3 years of project management experience in IVD or life science related industryWillingness to learn and develop in a complex regulated environment. Experience of project management tools and methodologies (waterfall, agile, MS project, Smartsheet’s)Good attention to detail. Basic understanding of a product development lifecycle. Travel (If Applicable):20% to Waters sites and colaborators. In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.
Education:
Education:
Education:- Bachelor’s degree in Life Sciences, Engineering, or related field
Bachelor’s degree in Life Sciences, Engineering, or related field
- Project Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable.
Project Management Professional (PMP) certification. Agile PM or equivalent type qualification preferable.
Experience:
Experience:
Experience:- Self-starting, growth mindset with the ability work independently and as part of a team.
Self-starting, growth mindset with the ability work independently and as part of a team.
- Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc across organisation.
Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc across organisation.
- Understanding of the IVD product life-cycle n particular how thois relates to software.
Understanding of the IVD product life-cycle n particular how thois relates to software.
- Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively.
Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively.Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc effectively.
- Experince of managing software developmnet [rject in the life science industry.
Experince of managing software developmnet [rject in the life science industry.Experince of managing software developmnet [rject in the life science industry.
Competencies:
Competencies:
Competencies:- 2-3 years of project management experience in IVD or life science related industry
2-3 years of project management experience in IVD or life science related industry
- Willingness to learn and develop in a complex regulated environment.
Willingness to learn and develop in a complex regulated environment.
- Experience of project management tools and methodologies (waterfall, agile, MS project, Smartsheet’s)
Experience of project management tools and methodologies (waterfall, agile, MS project, Smartsheet’s)
- Good attention to detail.
Good attention to detail.
Basic understanding of a product development lifecycle.
Basic understanding of a product development lifecycle.Basic understanding of a product development lifecycle.
Travel (If Applicable):20% to Waters sites and colaborators.
Travel (If Applicable):20% to Waters sites and colaborators.
Travel (If Applicable):In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.
In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.