R&D Program Director

at  Inogen

JOB SUMMARY:

Inogen is centralizing project management via the establishment of its Transformation Management Office (TMO). This is a unique opportunity to help build this organization from the ground up while immediately jumping in to lead critical medical device projects in the business.
In alignment with Inogens strategy and strategic priorities, we are seeking a highly skilled and experienced PMO Program Director to join our TMO at Inogen. This role is pivotal in managing and executing complex, multi-device product development projects in alignment with Inogens strategic priorities. The successful candidate will be responsible for the full project lifecycle, from concept to commercialization, ensuring that all projects are delivered on-time, within budget, and meet high-quality standards.
Reporting to the Vice President (VP) of the TMO, you will significantly contribute to the success of Inogen and build capabilities and execute programs that shape the future of the company.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Highly collaborative and team-oriented, while also able to work independently.
• Strong leadership skills, able to motivate team members to achieve project goals.
• Excellent organizational and time management skills.
• Ability to problem-solve, work under pressure, and effectively manage stress.
• Excellent communication and interpersonal skills, capable of working across various teams and organizational levels.
• Effective conflict resolution skills.

QUALIFICATIONS:

• Bachelor’s or Master’s degree in Engineering, Biomedical Sciences, or a related field. Ph.D. is a plus.
• 12+ years of experience managing technical product development.
• Minimum of 10 years of experience in R&D within the medical device industry, with at least 5 years in a leadership role.
• Experience with medical device capital equipment development strongly preferred.
• Advanced knowledge/proficiency ISO 13485, MDD or MDR, required.
• Advanced knowledge in FDA GMP and ISO regulated quality systems, required.
• Knowledge of global regulatory landscape, required.
• Knowledge of global standards and regulations for Design Controls, Risk Management, and Electrical Safety for Medical Devices.
• Demonstrated aptitude for successfully managing multiple projects, of varying complexity, within the specified guidelines, timeframes and budgets.
• Demonstrated understanding of electrical, mechanical, and software engineering practices at the system level.
• Proven ability to handle confidential and sensitive information, work under pressure, and manage stress effectively.
• Ability to work in a fast-paced, constantly changing environment and manage multiple projects in an organized, timely manner.
• Project management certification from PMI or equivalent, preferred.
• Fluent in MS Project, Excel and other MS Office applications, required.
• Strong understanding of technical concepts and ability to effectively collaborate with technical teams.
• Exceptional project management skills, capable of managing multiple projects simultaneously.
• Excellent interpersonal and communication skills, capable of working across various teams and organizational levels.
• Strategic thinking with the ability to align technical efforts with business goals.
• Proficiency in project management tools and software; PMP or similar certifications are a plus.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

• Contribute and utilize standardized templates and processes for the TMO.
• Take projects from original concept through final implementation.
• Aid in the management of Inogens project roadmap and enterprise program roadmap.
• Lead a cross-functional team through the Product Development cycle, from concept to commercialization, in accordance with customer development agreements.
• Manage a portfolio of complex initiatives spanning multiple lines of business.
• Provide on-site leadership, building and motivating team members to meet project goals and adhere to responsibilities and project milestones.
• Ensure successful project delivery by meeting or exceeding customer expectations regarding project deliverables.
• Manage full project life cycle ownership, including planning, external vendor relationships, communication, resources, budget, change, risks, and issues.
• Support the development of estimates and detailed project plans for all phases.
• Procure resources to achieve project objectives in planned timeframes and manage project scope and changes.
• Define the Statement of Work and Specifications for requested goods and services.
• Develop and manage project and program engagement aspects, including planning, external vendor relationships, communications, resources, budget, change, risks, and issues.
• Provide progress reports to key stakeholders and support quality control and issue resolution.
• Coach, mentor, and supervise project team.
• Ensure that projects and programs proceed according to scope, schedule, budget, and quality standards.
• Support the continued development of best practices, templates, policies, tools, and partnerships to expand and mature these capabilities for the organization.
• Assist with any other duties as assigned.