Manufacturing Engineer |Medical Device| | North Haven| CT|Grand Rapids MI

Job Title: Manufacturing Engineer

Location: Grand Rapids, MI /North Haven, CT (Onsite)

Duration: Long Term

Job Description

We are seeking a highly motivated and results-oriented Manufacturing Engineer to join our team in Grand Rapids, MI (or) North Haven, CT. This is a long-term, on-site position focused on Automation Equipment Validation and process development within the medical device industry.

Key Responsibilities

Equipment and Process Development:
• Collaborate with equipment suppliers and machine builders throughout the design and development phases of new equipment.
• Design and optimize processes for semi-automated and automated equipment, utilizing joining technologies, dispensing, cannula tipping, and pad printing techniques.
• Conduct print reviews and collaborate with design teams to ensure accurate and up-to-date manufacturing specifications.

Quality And Compliance
• Ensure adherence to Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) systems.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV) as required.
• Troubleshoot and resolve quality, safety, efficacy, cost, or delivery issues related to components and finished devices.

Project And Change Management
• Provide manufacturing engineering expertise for specific projects, including change analysis, risk assessment, and manufacturing readiness assessments.
• Conduct qualification, verification, and validation activities for medical device production.
• Collaborate effectively with cross-functional teams (CFTs) including Quality Engineering to troubleshoot production floor issues, manage projects, and document progress.

Continuous Improvement
• Actively participate in technology development, material and product testing, specification preparation, Six Sigma projects, process studies, and improvement initiatives.
• Prepare reports to document findings and recommendations for continuous improvement.

Education & Experience
• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
• Minimum of 5 years of experience in manufacturing engineering, preferably within the medical device industry.
• Proven experience collaborating with equipment suppliers and supporting machine builders during equipment design and development.
• Extensive experience working with semi-automated and automated equipment.
• Proficiency in developing and optimizing processes for joining technologies, dispensing, cannula tipping, and pad printing.
• Working knowledge of QMS and ERP systems.
• Familiarity with IQ/OQ/PQ/TMV processes for medical device manufacturing.

Skills & Abilities
• Strong problem-solving skills and the ability to identify and troubleshoot complex manufacturing issues.
• Excellent communication (written and verbal) and collaboration skills, with a proven track record of working effectively in cross-functional teams.
• Ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Proficiency in Six Sigma methodologies and a strong commitment to continuous improvement.