Hybrid Project Engineer – QE/ME – Contract (#2870)

Job Description:

Position Title: Contract Hybrid Project Engineer – QE/ME

Reports To: Director of Quality (dotted line to Engineering Manager)

Effective: November 13, 2023

Department: Quality / Operations

DESCRIPTION:
We are seeking a highly motivated and skilled Project Engineer to join our dynamic team, who has extensive experience in quality engineering, including expertise in medical device equipment qualifications, good knowledge of manufacturing and project management skills. As a Project Engineer, you will be a core team member of our Building 1 Renovation project along with our construction project manager and manufacturing manager. You will play a crucial role in helping us expand our production capacity and capabilities to meet our aggressive future growth. In this role supporting our Building 1 Renovation project, you will oversee the new equipment builds, installations, and qualifications as well as existing equipment moves and requalification.
Our Building 1 Renovation project will take over 1 year to complete and this assignment could be extended to 2+ years, depending on performance and when we activate our building 3 new construction project.

RESPONSIBILITIES:

1. Oversee and manage the new equipment build plans, FATs, equipment installations, and SATs.
2. Lead IQs, OQs, and PQs for new equipment and IQs and OQs for existing moved equipment.
3. Develop and execute equipment calibration, GR&R studies, and test method validations.
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. Work with outside vendors for equipment, services, and timelines.
8. Create work instructions and on-the-job training procedures and training new equipment.
9. 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 5 years of engineering experience preferably in the medical device industry
2. Proficient knowledge and application of GMPs & ISO 13485 system requirements, quality systems, process controls, and knowledge of equipment qualifications tools (i.e., IQ, OQ, & PQ). A minimum of two years of experience working in a medical manufacturing facility is required.
3. Experience in new product development, process development, process characterization and validation, design control, software validation, database management, and CAD is a plus.

1. Able to successfully manage complex projects in manufacturing equipment installation and qualifications, and new technology integration.
2. Must be able to work in a fast-paced cross-functional team environment and effectively communicate and present to all levels of an organization.
3. Possess excellent interpersonal skills along with strong analytical, change management, influencing, and problem-solving skills.
4. BS Engineering degree required. Advanced degree such as MS Engineering and/or MBA is a plus.