Job Specifications
About Warwick Consulting:
Warwick Consulting LLC is a leading provider of quality, regulatory, and engineering solutions to the medical device industry. We support clients across the entire product lifecycle from early-stage research and development through commercialization focusing on software assurance, risk management, cybersecurity, and product compliance. With a proven track record across 25+ therapeutic areas and over 35 commercialized medical devices, Warwick Consulting brings unmatched depth in medical technology development.
Position Summary:
We are seeking an experienced Project Manager to lead cross-functional software development programs from concept through commercial launch. This role will be responsible for driving alignment across Engineering, Design, Product, Regulatory, Quality, and Commercial teams, ensuring timely and high-quality delivery of software products. The ideal candidate brings strong program execution skills, experience guiding teams through structured development lifecycles, and a proven ability to influence without authority. This position requires excellent communication, the ability to manage competing priorities, and a track record of launching complex software products in regulated environments.
Key Responsibilities:
Lead end-to-end software product delivery, including planning, execution, risk management, and launch readiness
Partner with cross-functional stakeholders (Engineering, UX, Quality, Regulatory, Security, Product, and Commercial) to align priorities, requirements, timelines, and resources. Facilitate decision-making by driving clarity, surfacing trade-offs, and ensuring stakeholders have the information needed to move programs forward
Build and manage integrated project plans, track milestones, identify risks, and implement mitigation plans
Support development lifecycle governance (requirements, design, verification/validation, release readiness reviews)
Ensure program deliverables meet quality and compliance expectations, escalating blockers and risks proactively
Champion clear communication and alignment across teams through status updates, program dashboards, and structured meeting cadences
Foster collaboration across diverse technical and business groups, ensuring high-trust partnerships and shared accountability
Drive continuous improvement by identifying and implementing project management best practices and operational efficiencies
Lead design change assessments, including evaluation of risk impact, documentation updates, and coordination of necessary verification activities.
Ensure compliance with applicable regulations (e.g., 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304).
Drive risk management activities throughout the development lifecycle, supporting creation and maintenance of FMEAs, hazard analyses, and other risk tools.
Partner with R&D, Regulatory, and Systems Engineering teams to ensure quality is integrated into product and process development.
Qualifications:
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Software Engineering, or a related technical field.
5 years of experience in the medical device industry, with a focus on NPD.
Strong understanding of design control requirements and product lifecycle management for both hardware and software products.
Experience with electro-mechanical systems, embedded systems, and/or regulated software (including IEC 62304).
Deep familiarity with risk management principles (ISO 14971) and quality system regulations (21 CFR Part 820, ISO 13485).
Proven ability to lead cross-functional teams and manage quality-related deliverables.
Excellent analytical, documentation, and communication skills.
About the Company
Since 2011, Warwick Consulting has been a leader in medical device consulting, offering a comprehensive suite of services including non-compliance remediation, software assurance, cybersecurity, Software as a Medical Device (SaMD), Research & Development, and verification & validation. We specialize in navigating the complex regulatory landscape, ensuring software quality and security, protecting medical devices from cyber threats, and advancing healthcare through innovation and rigorous testing. Our approach is holistic, in...
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