Project Manager - Urology Division (SW/Systems)
About The Position
Establish and lead a cybersecurity-focused program team, coordinating with Engineering, Quality, Regulatory, and Project Management functions to embed cybersecurity and compliance into platform decisions Partner with business decision owners, NPD, and sustaining teams to define, vet, and align project priorities, ensuring cybersecurity implications and interdependencies are assessed prior to project initiation Lead development and implementation of enhanced assessment mechanisms to evaluate ecosystem and platform interactions, risks, and competing resource demands Facilitate early risk identification to enable proactive mitigation and realistic project timelines and scopes Drive objective, business-focused decision-making that incorporates regulatory strategies and requirements Clarify, document, and communicate decisions and decision ownership to ensure accountability Optimize operational workflows to reduce delays and resource conflicts Develop and maintain comprehensive project documentation, including risk assessments, mitigation plans, decision logs, and status reports Champion continuous improvement by identifying process gaps and implementing best practices across the project lifecycle Support training and knowledge-sharing initiatives to enhance cross-functional understanding of platform governance and regulatory requirements
Requirements
- Bachelor's degree required (Engineering, Project Management, or Business preferred)
- 5+ years of relevant experience in Project management experience leading cross-functional teams, including scope, schedule, and budget management
- Demonstrated experience in medical device software or systems-related functions
- Strong understanding of Software Development Life Cycle (SDLC), Agile, and DevOps practices
- Experience managing software or systems development projects in compliance with IEC 62304 software lifecycle requirements
- Proven ability to manage complex interdependencies across products and platforms
- Strong risk management experience, including cross-functional assessments and regulatory strategy integration
- Exceptional communication skills with the ability to drive consensus and communicate clearly at a business and technical level
- High emotional intelligence, situational leadership skills, and ability to influence without direct authority
- Ability to travel up to 15%, including international travel
Responsibilities
- Establish and lead a cybersecurity-focused program team
- Coordinate with Engineering, Quality, Regulatory, and Project Management functions
- Embed cybersecurity and compliance into platform decisions
- Partner with business decision owners, NPD, and sustaining teams to define, vet, and align project priorities
- Ensure cybersecurity implications and interdependencies are assessed prior to project initiation
- Lead development and implementation of enhanced assessment mechanisms
- Evaluate ecosystem and platform interactions, risks, and competing resource demands
- Facilitate early risk identification to enable proactive mitigation and realistic project timelines and scopes
- Drive objective, business-focused decision-making that incorporates regulatory strategies and requirements
- Clarify, document, and communicate decisions and decision ownership to ensure accountability
- Optimize operational workflows to reduce delays and resource conflicts
- Develop and maintain comprehensive project documentation
- Champion continuous improvement by identifying process gaps and implementing best practices across the project lifecycle
- Support training and knowledge-sharing initiatives to enhance cross-functional understanding of platform governance and regulatory requirements
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
