New Product Introduction Project Manager (MedSurg)

SOLVENTUM•San Antonio, TX

1d•$143,200 - $196,900•Hybrid

About The Position

Solventum is a new healthcare company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges. We pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. As a New Product Introduction Project Manager, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. You will lead complex NPI programs with full accountability, setting project strategy and guiding cross-functional teams to ensure alignment with broader portfolio and global initiatives. You will own all aspects of assigned projects including project scope, plan, budget, resource and risk management, problem solving, team and organizational communication while serving as the primary point of contact for project stakeholders. You will serve as the core team leader for cross-functional project teams, setting direction, driving ownership, and ensuring disciplined execution within scope, budget, and timelines in compliance with quality standards and functional requirements. You will effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities. You will lead programs through the full product development lifecycle, from initiation and concept through development, verification/validation, and commercialization, in alignment with the defined phase-gate process. You will ensure robust design and development practices, including implementation of design controls compliant with 21 CFR 820, ISO 13485, and ISO 14971 requirements. You will establish and maintain project governance and controls, ensuring consistency, transparency, and adherence to organizational standards. You will evaluate technical and program risks, making informed decisions, and ensuring appropriate countermeasures are in place to enable successful execution. You will collaborate with internal teams, suppliers, and external partners, including globally distributed stakeholders, anticipating challenges, aligning timelines, and facilitating timely decision-making. You will communicate effectively across all levels of the organization, providing clear and proactive project updates, and escalating risks and issues as needed. You will develop and deliver executive-level communications, including clear, concise presentations and program updates that drive alignment, support decision-making, and provide transparency on status, risks, and key milestones.

Requirements

Bachelor’s degree AND 5+ years of applied program, project management, and/or leadership experience in medical device industry or other highly regulated healthcare industry.
Three (3) years experience leading motivate cross-functional teams, and driving projects to completion on time and within budget, while satisfying quality and performance requirements.
Three (3) Years of demonstrated experience leading New Product Introduction (NPI) programs and executing phase-gate / gate review processes, with emphasis on early-stage development and commercialization
Two (2) Years hands-on experience with project planning tools, including MS Project and/or Smartsheet
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

Master's degree in engineering from an accredited institution
Strong understanding of medical device development and design controls, including FDA and ISO (e.g., 21 CFR 820, ISO 13485) requirements
Strong organizational skills and demonstrated ability to manage stakeholder communication in a matrix organization, and to collaborate with diverse and global cross-functional teams.
Proficiency in project management methodologies, tools, and best practices; PMP or equivalent certification preferred.
Demonstrated experience of working closely with internal stakeholders and suppliers to deliver results.
Customer focus and results driven.
Strong analytical and problem-solving skills.
Action oriented.
Demonstrated negotiation and conflict resolution skills.
Ability to work in a dynamic and fast-paced environment.
Situational adaptability.
Fluent in English.
Strong verbal and written communication skills.

Responsibilities

Leading complex NPI programs with full accountability, setting project strategy and guiding cross-functional teams to ensure alignment with broader portfolio and global initiatives.
Owning all aspects of assigned projects including project scope, plan, budget, resource and risk management, problem solving, team and organizational communication while serving as the primary point of contact for project stakeholders.
Serve as the core team leader for cross-functional project teams, setting direction, driving ownership, and ensuring disciplined execution within scope, budget, and timelines in compliance with quality standards and functional requirements.
Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities
Leading programs through the full product development lifecycle, from initiation and concept through development, verification/validation, and commercialization, in alignment with the defined phase-gate process.
Ensuring robust design and development practices, including implementation of design controls compliant with 21 CFR 820, ISO 13485, and ISO 14971 requirements.
Establishing and maintaining project governance and controls, ensuring consistency, transparency, and adherence to organizational standards.
Evaluating technical and program risks, making informed decisions, and ensuring appropriate countermeasures are in place to enable successful execution.
Collaborating with internal teams, suppliers, and external partners, including globally distributed stakeholders, anticipating challenges, aligning timelines, and facilitating timely decision-making.
Communicating effectively across all levels of the organization, providing clear and proactive project updates, and escalating risks and issues as needed.
Develop and deliver executive-level communications, including clear, concise presentations and program updates that drive alignment, support decision-making, and provide transparency on status, risks, and key milestones.
Corporate policies, procedures and security standards are complied with while performing assigned duties.