Process Engineer
Location: Phoenix, Arizona
About Our Client:
Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work with some of the top technical professionals in the industry who are bringing cutting-edge products to forefront. Offering results-driven people a place where they can truly make a difference on a daily basis, this is an opportunity you will not want to miss!
Key Responsibilities:
- Conducting process and equipment validation activities to ensure compliance with regulatory standards.
- Supporting and executing process characterization studies to optimize manufacturing performance.
- Managing the technical transfer of processes and equipment from development to production.
- Creating and releasing manufacturing procedures, equipment specifications, and control plans.
- Performing IQ, OQ, and PQ validation studies for equipment, processes, utilities, and software systems.
- Developing and updating technical documentation such as process maps, manufacturing routings, and PFMEA reports.
- Providing training sessions for manufacturing team members to ensure proper understanding of processes and validation requirements.
- Participating in project planning, scheduling, and progress tracking to meet production timelines.
- Managing documents and document changes through the company's document control system, including creation, revision, review, and approval.
- Collaborating with cross-functional teams to facilitate timely document approval and release processes.
- Ensuring compliance with regulatory standards such as ISO 13485, 21 CFR 820, and 21 CFR Part 11 throughout validation and documentation activities.
Qualifications:
- Bachelor's degree in Science, Engineering, or a related technical field is required.
- Minimum of 3 years’ experience in new product development and/or manufacturing process design and development within the medical device industry.
- Applied technical understanding of manufacturing equipment and processes specific to medical device manufacturing.
- Applied technical understanding of product lifecycle management and change management for medical devices.
- Basic communication and project management skills to coordinate cross-functional activities effectively.
- Strong interpersonal skills, with proficient written and oral communication abilities.
- Basic analytical and problem-solving capabilities to identify and address manufacturing issues.
- Proficiency in Microsoft Office Suite and Adobe Acrobat for documentation and report generation.
- NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company
