Medical Device Project Manager

Description

The Medical Device Project Manager 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 Medical Device Project Manager will work closely with the engineering, regulatory affairs, quality assurance, commercial, operations, portfolio, and supply personnel to facilitate and execute project activities. The 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.
 

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

• 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 

• Must have strong work ethic.
• Analytical & problem-solving skills & ability to multitask.
• Solutions-oriented problem solver.
• Excellent planning, communication and organizational skills.
• Strong background in Project Management best practices, preferably according to PMI processes.
• Excellent oral and written communication skills as well as excellent presentation skills with ability to conduct presentations comfortably to large groups.
• Demonstrated capability for problem solving, decision making, and conflict resolution.
• Proven leadership ability with an emphasis on accountability and conflict management.
• Strong relationship building and interpersonal skills.
• Strong understanding of FDA/ISO Design Control requirements required.
• Attention to detail and follow through required.
• Passion for product quality and excellence required.
• Strong technical writing and organizational skills required.
• Ability to multitask in a fast-paced team environment required.

Qualifications (Experience and Education)

• Bachelors’ degree required. Scientific or health related field, preferred.
• 5 years’ experience in project management experience, required; in medical device, regulatory, preferred.
• 5 years’ experience in medical device industry, 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, required.
• Advanced knowledge in FDA GMP and ISO regulated quality systems, required.
• Knowledge of global regulatory landscape, 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.