Project Manager

Intellectt Inc; Dublin (CA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Intellectt Inc is seeking an experienced Project Manager to drive a dual pump program supporting Parkinson’s treatment. You will own the complaint evaluation lab setup at the Dublin, California site, coordinate cross-functional teams across multiple locations, and manage end-to-end scheduling and milestones for the product launch.

The role requires >10 years of PM experience in regulated medical device environments, strong risk management, and hands-on site integration, with a hybrid schedule

Qualifications

• Strong project management experience handling complex, multi-site programs.
• Experience with design/tech transfer or similar multi-discipline programs is preferred.
• Regulated medical device knowledge or FDA-regulated industry exposure is a plus.

Responsibilities

• Own the end-to-end setup and execution of the complaint evaluation lab at Dublin, CA.
• Coordinate cross-functional activities across multiple teams and sites to drive the program.
• Develop and maintain integrated project schedules and milestones across all workstreams.
• Manage lab equipment, test methods, and qualification activities in collaboration with site teams.
• Facilitate core and sub-team meetings to monitor progress and mitigate risks.

Skills

Project management

Cross-functional collaboration

Risk management

Scheduling

Stakeholder coordination

Regulatory awareness

Education

Bachelor's degree in engineering or technical field

Tools

MS Project / Planner

Excel

Job description

The role is for a Project Manager who will primarily support dual pump program, which involves developing a next-generation pump to replace the current pump used for Parkinson’s treatment with Duopa/Duodopa therapy.

• The individual will support the setup and launch of a complaint evaluation lab and the associated processes for the new product, with the lab located at Dublin, California site.
• We will be the design owner and manufacturer of record for the new pump, so the role will support activities related to complaint evaluation and ensuring the lab is properly established for the product launch.
• The Project Manager will work closely with both the Design Quality Assurance team and the Dublin site team, with the position ultimately reporting to Hitesh and working closely with Sean’s team as well.
• The individual will take primary ownership of managing the complaint evaluation lab workstream, which has already been initiated but currently requires a dedicated person to drive the work instead of having it managed by ad hoc team members.
• The role will involve development and planning activities, including ensuring all required test methodologies and equipment are identified and that the associated methods for using the equipment are developed and qualified.
• The Project Manager will work with a cross-functional team to coordinate technical activities, with many of the technical team members based in Northern Illinois.
• Once the equipment and methods are defined and qualified, the individual will work closely with the Dublin site team on equipment procurement, installation, and any required qualification activities at the site.
• A key responsibility will be developing and maintaining an end-to-end integrated project schedule that brings together activities across multiple teams and sites.
• The individual will be responsible for establishing and managing core team meetings and any required sub-team meetings to monitor execution, track deliverables, and ensure activities are completed on time.

Qualifications & Requirements / Skillset

• Strong project management experience is required, particularly the ability to manage complex projects involving multiple functions, teams, and locations.
• The ideal candidate will have experience with design transfer, product transfer, technology transfer, factory transfer, or a similar type of transfer project involving multiple disciplines and teams.
• The candidate should have enough technical and industry knowledge to understand the overall transfer process, effectively manage the program, identify potential issues, and help the team de-risk the project.
• The individual should be able to proactively identify schedule risks, program risks, dependencies, and potential delays and work with the appropriate teams to develop mitigation plans.
• The role is expected to be approximately 60–70% project management and 30–40% technical or industry know-how related to the transfer and implementation activities.
• Strong cross-functional communication and collaboration skills are important, as the individual will need to work effectively with technical teams, site teams, quality teams, and other stakeholders across different locations.
• The candidate should be comfortable working with multi-disciplinary teams and coordinating people who may have different technical backgrounds and responsibilities.
• A bachelor’s degree is preferred, ideally in engineering, a technical discipline, or another field related to the industry.
• Experience working in a regulated environment is important, with medical device or FDA-regulated industry experience preferred because the project is supporting a medical device program.
• The hiring team is looking for a fairly seasoned Project Manager with more than 10 years of overall experience.
• Strong project management experience is required, with the ability to lead and deliver complex projects involving multiple sites, teams, activities, and dependencies.
• Project management certifications are a plus, but Agile certifications such as CSM, PSM, or SAFe are not specifically required.
• The candidate should have experience building integrated program schedules and driving project execution through completion rather than only supporting individual project activities.
• The individual should be able to take ownership of the role and independently drive the workstream forward, as this person will be the primary owner responsible for getting the lab setup and associated processes moving.
• The project is expected to continue through approximately April or May of next year, with the initial months expected to be particularly busy as the lab and processes are being established.
• The role is ideally based at the Dublin, California site because of the hands-on nature of integrating the equipment and activities into the lab.
• The position follows a hybrid schedule, with Tuesday, Wednesday, and Thursday expected to be onsite at the Dublin location.
• The candidate should also have flexibility to be onsite on Mondays or Fridays when business needs require additional onsite support.
• The hiring team is looking to move quickly with this opening and would like to have candidates available for interviews as soon as possible.
• Interviews will be conducted through a 30-minute video call.
• The position provides an opportunity for the Project Manager to take ownership of a new and impactful workstream, help develop and implement the complaint evaluation lab process and program, and make a direct impact on the team and product launch.
• The workload is expected to be around 40 hours per week for most of the project, particularly during the initial setup period, although there may be some weeks where a full 40 hours is not required.
• There will consistently be at least 25–30 hours of work per week, with the workload expected to be heavier during the first several months as the program gets established.