R&D Project Manager - 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 Inogen’s strategy and strategic priorities, we are seeking a highly skilled and experienced R&D Project Manager to join our TMO at Inogen. This role is pivotal is responsible for managing Inogen's projects, including new product development, design changes, and sustaining or maintenance projects. This position coordinates cross-functional resources and schedules to deliver project plans and deliverables on-time, within budget, and in alignment with company-wide priorities. The R&D Project Manager will work closely with the engineering, regulatory affairs, quality assurance, IT, operations, and supply personnel to facilitate and execute project activities. The R&D Project Manager will ensure that regulatory standards, international registrations, and design control activities are thoroughly planned, documented, and executed to comply with and adhere to best practices in the medical device industry. 

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. 

Responsibilities (Specific tasks, duties, essential functions of the job) 

• Contribute and utilize standardized templates and processes for the TMO.
• Take projects from original concept through final implementation.
• Aid in the management of Inogen’s project roadmap and enterprise program roadmap.
• Oversee and coordinate all aspects of priority R&D projects in the TMO and serve as project manager between business teams. Defines project scope and objectives.
• Assess project issues and develop resolutions to direct the analysis of, and solution to problems; meet productivity, quality, and client-satisfaction goals.

• Manage projects of varying size and complexity from concept to production per internal procedures and regulatory standards for new products.
• Manage design change projects for software updates, sustaining activities, new market releases, product updates, and standard updates.
• Collaborate with product management and engineering to manage product portfolio life cycle planning to ensure that products are compliant with regulatory standards as they are updated, published, and adopted.
• Manage project timelines, milestones, budget, and BOM costs, and report project status to team and management, as applicable.
• Effectively communicate and collaborate with Engineering, Product Management, Regulatory, Quality, and Ops, to define project requirements, make decisions, and accomplish objectives.
• Conduct meetings and track project status to set goals, monitor timelines, align expectations, facilitate cross-functional communication, and ensure task completion.
• Coordinate product development activities, including development of plans and strategies, creation of customer facing labeling and interfaces, and hardware integration/testing, software development/testing, validations, market release activities according to product plans and international roll-out strategies including registration/clearance activities and reimbursement.
• Coordinate and support engineering verification activities, including scheduling, planning, delegating tasks, and releasing documentation.
• Promote teamwork and motivate others to solve challenges in a productive and positive manner.
• Assist in project management and product development process improvements.
• Maintain regular and punctual attendance.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned

Knowledge, Skills, and Abilities  

• Highly collaborative and team-oriented, while also able to work independently.
• Ability to work in a dynamic and fast-paced environment and multitask appropriately.

• Strong prioritization skills to address highest-value opportunities.
• Knowledge of project management tools.
• Ability to effectively interface with different departments within the company.

• Experience with development, implementation, and budgetary controls.

• Excellent planning and organizational skills.
• Proven analytical & problem-solving skills.
• Solutions-oriented problem solver.
• Must have strong work ethic.
• Effective conflict resolution skills.

Qualifications (Experience and Education) 

• Bachelors’ degree in Engineering required.
• Experience in medical device capital equipment development, strongly preferred.
• 5 years’ experience in project management experience, required in medical device or regulatory, required.
• 5 years’ experience managing technical product development required.
• 5+ years of experience as an Engineer developing products, preferably in the medical device industry.
• 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.
• Exceptional understanding of the product development lifecycle required.
• Project management certification from PMI or equivalent, preferred.
• Fluent in MS Project, Excel and other MS Office applications, required.
• Advanced knowledge/proficiency ISO 13485, MDD or MDR, preferred.
• Advanced knowledge in FDA GMP and ISO regulated quality systems, preferred.
• Knowledge of global regulatory landscape, preferred.
• 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 preferred.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Disclaimer 

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.