Project Engineer – Contract (#2562)

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 production capacity and capabilities to meet our aggressive future growth by overseeing our Building 1 Renovation project (including equipment moves and qualifications) and our new Building 3 construction project (including buildout of new production cells). 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 a two-year assignment with the potential to go from a temporary to permanent project engineering role.

RESPONSIBILITIES:

1. Lead building construction (new and renovation), new equipment, equipment relocation, and technology integration projects.
2. Perform project plans, develop 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.
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.

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 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 construction, manufacturing equipment installation and qualifications, and new technology integration. Project management experience in new products and process development is a plus.
4. Well versed in project management software systems, and database management. Experience in Visio, Power Bi, and AutoCAD is 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 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 and has managed large capital projects.
9. BS Engineering or BA Business degree required. Advanced degree such as MS Engineering and/or MBA is a plus.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. In accordance with the law, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position