Process Engineer II

Location: Wilmington, Delaware

About Our Client:

Our Hiring Company, a best-in-class Medical Device Manufacturer has an opening for a new team member at their facility. Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 100 years and has been rated as Forbes top 14 most innovative companies in the world. With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top-talented engineers towards making a significant contribution to our society.

Key Responsibilities:

• Providing engineering support to the design, development, and qualification of products and processes in compliance with company and regulatory standards.
• Participating in and providing manufacturability insight for new product development to ensure viable production processes.
• Serving as a process leader for developing or transferring production processes, overseeing overall performance, and ensuring validation requirements are met.
• Actively leading and participating in formal process validations, ensuring compliance with validation protocols and preparing well-documented reports.
• Installing production and process equipment while supporting Installation Qualification (IQ), Operational Qualification (OQ), Pre-Process Qualification (PQ), and formal PQ validation activities.
• Serving as a problem solver for product and process issues, applying engineering tools and techniques to resolve challenges and implement process improvements.
• Participating in project team meetings, design reviews, and formal project assessments, providing valuable engineering insights.
• Contributing to project planning, including cost estimation, scheduling, and defining performance requirements.
• Preparing and presenting technical reports and presentations that effectively communicate technical activities to various audiences, including executive management and regulatory bodies.

Qualifications:

• Bachelor's degree in Mechanical, Biomedical, or a similar engineering discipline from an accredited institution.
• Minimum of 3 years of experience in product and process development within the medical device industry, with increasing levels of responsibility.
• At least 1 year of experience in the medical device industry, with a strong understanding of regulatory and quality requirements.
• Calibration, metrology, and tooling experience to ensure precision and compliance in manufacturing processes.
• Hands-on experience in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ) to support production readiness and compliance.
• Expertise in applying Design for Manufacturability (DFM), Design for Assembly (DFA), and Lean Six Sigma principles and tools.
• Strong analytical and problem-solving skills with the ability to implement effective solutions.
• Proven ability to design, develop, and qualify new or novel medical device production processes.
• Excellent communication skills, with the ability to explain complex engineering problems to non-engineering personnel and deliver technical presentations to executive leadership.
• Proficiency in MS Office Suite for documentation, analysis, and reporting.
• Experience working within FDA design control guidelines and understanding cross-functional interactions in new product and manufacturing process development.
• Familiarity with regulatory submissions and preparing technical reports suitable for FDA review.

Interested Candidates please apply on our website at .

For more information about our services and great opportunities at JBL Resources, please visit our website: .

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