Job Title
Senior Project Manager, R&D
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About the Role
This position is responsible for project managing (scope setting, project planning, and execution) the implementation of manufacturing processes and supply chain systems to support new product development and launch. The role involves working within a quality management system, managing a cross-functional team, and interfacing with leaders to ensure organizational alignment and stakeholder management.
This is an individual contributor role requiring professional judgment, working independently with minimal supervision.
The successful candidate will have:
* Strong experience in engineering/project management in a regulated industry.
* Demonstrated leadership skills to motivate and influence cross-functional teams on moderate projects.
* Excellent communication, interpersonal, analytical, and problem-solving skills.
* Knowledge of FDA and international medical device regulations.
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Main Responsibilities
The Senior Project Manager, R&D will be responsible for:
1. Setting manufacturing strategy and gaining alignment with leadership.
2. Delivering manufacturing components of new product programs, focusing on scope, planning, quality, budget, supply management, and Design for Manufacturability (DFM).
3. Leading a diverse project team to achieve launch deliverables, assuming responsibility for team and operational outcomes.
4. Collaborating with site leadership during design to ensure timely, compliant, and successful process transfer and product commercialization.
5. Developing communication strategies for project updates to stakeholders.
6. Aligning project strategies with regulatory pathways and requirements.
7. Supporting supply chain strategies and sourcing component qualifications.
8. Determining demand and implementing manufacturing capacity solutions.
9. Driving Lean Manufacturing practices throughout the project lifecycle.
10. Managing capital expenditures and operational expenses, supporting negotiations and installations.
11. Escalating and resolving project obstacles to ensure progress.
12. Establishing project priorities and using management tools for delivery.
13. Participating in resource selection, training, and performance appraisal.
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Requirements
To be considered for this role, you must have:
* A Bachelor's Degree in Engineering or Science, with project management certification preferred.
* At least 7 years of engineering/project experience in a regulated industry.
* High proficiency in PC skills, including MS Excel, PowerPoint, and MS Project.