JOB DESCRIPTION:
We are seeking a highly motivated and skilled Project Engineer to join our dynamic team, who has extensive experience in project management (including leading building construction projects) and expertise in medical device equipment qualifications. As a Project Engineer, you will play a crucial role in helping us expand our maintenance and facilities capabilities and leading our construction projects to optimize our production capacity and capabilities, facility layouts and other aggressive future growth projects. As part of this assignment, there could be sub-projects to manage that relate to integrating new technologies and equipment to help us expand our manufacturing capabilities, capacity, and product portfolio.
This is an onsite contractor role at our Norwood campus.
RESPONSIBILITIES:
1. Lead building construction (new and renovation), new facility equipment installation, equipment relocation, and technology integration projects.
2. Develop statements of work, project plans, timelines, identify key milestones, and manage key project risks & critical path items.
3. Collaborate with cross-functional team members and key stakeholders.
4. Foster effective communication and teamwork to achieve project objectives. Hold internal and external stakeholders accountable to objectives and timelines.
5. 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.
6. Lead project meetings, publish minutes and action plans, hold team members accountable, and develop communication tools and executive summaries for assigned projects.
7. Assist with validation and qualifications on new and existing equipment or facilities in the business.
8. Work with outside vendors for equipment, services, and timelines.
9. Create procedures and training guides for new and existing equipment as needed.
10. Performs other related duties as assigned by management.
11. Track and manage project financial metrics by developing budgets, evaluating project proposals, and monitoring expenses.
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 and engineering 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. Proficient knowledge of industry standards such as NFPA, OSHA, and UL.
4. Able to successfully manage complex projects in construction, manufacturing equipment installation and qualifications, and new technology integration. Project management experience in new products and process development is a plus.
5. Well versed in project management software systems, Gant Charts, and database management.
Experience in Visio, Power Bi, and AutoCAD is a plus.
6. Having a project management certification is a plus.
7. Must be able to work in a fast-paced cross-functional team environment and effectively communicate and present to all levels of an organization.
8. Possess excellent interpersonal skills along with strong analytical, change management, influencing, and problem-solving skills.
9. Demonstrates good financial and business acumen and has managed large capital projects.
10. BS Engineering or BA Business degree required. Advanced degree such as MS Engineering and/or MBA is a plus.