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Project Manager

Goleta, CA | Full Time
Expired

Job Description

Medical Device – Project Manager

Location: Remote

Traveling required: Every 4-5 weeks you will be required to traveling to our headquarters in Goleta, CA.

Job Summary:

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:

  • 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:

  • 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.

Skills for Project Manager

The job skills required for Project Manager include Project Management, Planning, Leadership, Scheduling, Problem Solving,and Written Communication etc. Having related job skills and expertise will give you an advantage when applying to be a Project Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Project Manager. Select any job title you are interested in and start to search job requirements.

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Career Path for Project Manager

The following is the career advancement route for Project Manager positions, which can be used as a reference in future career path planning. As a Project Manager, it can be promoted into senior positions as a Planner Scheduler IV Construction that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Project Manager. You can explore the career advancement for a Project Manager below and select your interested title to get hiring information.

How to Become a Project Manager

If you are interested in becoming a Project Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Project Manager for your reference.

Step 1 Understand the job description and responsibilities of a Project Manager

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Step 2 Knowing the best tips for becoming a Project Manager can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

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