Title: Project Manager - R&D Process & Technology Integration Projects
Reports to: Director of Operations
Location: Southwest of Boston

JOB DESCRIPTION:
We are seeking a highly motivated and skilled Project Manager to join our dynamic team, who has extensive experience in project management and expertise in medical device equipment qualifications. As a Project Manager, you will play a crucial role in helping us implement a robust and effective new product development stage gate process and project management review process for R&D and technology integration projects. As part of this assignment, this person will help us develop and manage strategic roadmaps for our new technologies, R&D pipeline, and product portfolio.
This is a full-time, onsite role at our campus southwest of Boston. It is a one-year assignment with the potential to go from a temporary to permanent role.

RESPONSIBILITIES:

1. Lead R&D and new technology integration projects.
2. Perform project plans, develop timelines, identify key milestones, and manage key project risks & critical path items.
3. Develop formal project management structure and key stakeholder review process with dashboards, executive summaries, and project plans for all critical projects.
4. Collaborate with cross-functional team members and key stakeholders.
5. Foster effective communication and teamwork to achieve project objectives.
6. Develop an effective risk management process where potential risks and challenges are identified, risk mitigation strategies are implemented, and potential issues are resolved in a timely manner.
7. Lead project meetings, publish minutes and action plans, hold team members accountable, and develop communication tools and executive summaries for assigned projects.
8. Support the development and execution of process verification and validations for new equipment.
9. Work with outside vendors for equipment, and timelines.
10. Manage project expenses and capital expenditures.
11. Create procedures and training guides for new stage gate process and our project management.
12. Performs other related duties as assigned by management.

REQUIREMENTS:
The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation.

1. Minimum 8 years of project management experience, preferably in the medical device industry
2. Proficient knowledge and application of GMPs & ISO 13485 system requirements, and knowledge of equipment qualifications tools (i.e., IQ, OQ, & PQ).
3. Able to successfully manage complex projects in new product development, process development, manufacturing equipment installation and qualifications, and new technology integration.
4. Well versed in project management software systems, Gantt Charts, and database management. Experience with Agile Scrum, Monday.com, Visio, Power Bi, and AutoCAD are a plus.
5. Having a project management certification is a plus.
6. Must be able to work in a fast-paced cross-functional team environment, with minimal supervision, and effectively communicate and present to all levels of an organization.
7. Possess excellent interpersonal skills along with strong analytical, change management, influencing, and problem-solving skills.
8. Demonstrates good financial and business acumen, able to manage project financial expenses and large capital projects.
9. BS Engineering or BA Business degree required. Advanced degree such as MS Engineering and/or MBA is a plus.