We are seeking a skilled and experienced Manufacturing Engineer to join our team in Grand Rapids, MI. The ideal candidate will possess a strong background in medical device manufacturing, process development, and equipment support. The Manufacturing Engineer will work closely with cross-functional teams, quality engineering, and equipment suppliers to ensure efficient and effective production processes. This role requires hands-on experience with semi-automated and automated equipment, and a thorough understanding of various manufacturing technologies.
Key Responsibilities
1-Equipment and Process Development
Collaborate with equipment suppliers and support machine builders during kick-off and design phases.
Develop and optimize semi-automated and automated equipment processes.
Utilize joining technologies, dispensing, cannula tipping, and pad printing techniques.
Print Review and Design Collaboration:
Conduct print reviews and collaborate with design teams to update prints as necessary.
2-Quality and Compliance
Work within 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 needed.
Troubleshoot and resolve issues related to safety, efficacy, quality, cost, or delivery of components and finished devices.
3-Project and Change Management
Provide manufacturing engineering support to specific projects, including change analysis, risk analysis, and manufacturing readiness.
Conduct qualification, verification, and validation activities for medical device production.
Cross-Functional Collaboration:
Collaborate with Quality Engineering to provide manufacturing support.
Participate in cross-functional project teams, coordinating, managing, and documenting project work and progress.
Work with cross-functional teams (CFT) to troubleshoot production floor issues.
4-Continuous Improvement
Engage in technology development, material or product testing, specification preparation, Six Sigma, process studies, process improvements, and report preparation.
Education Qualifications & 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 in the medical device industry.
Proven experience working with equipment suppliers and supporting machine builders.
Extensive experience with semi-automated and automated equipment.
Proficiency in process development for various manufacturing processes including joining technologies, dispensing, cannula tipping, and pad printing.
Experience with QMS and ERP systems.
Familiarity with IQ/OQ/PQ/TMV processes.
Skills And Abilities
Strong problem-solving skills and ability to troubleshoot manufacturing issues.
Excellent collaboration skills and experience working in cross-functional teams.
Ability to manage multiple projects and prioritize tasks effectively.
Strong communication skills, both written and verbal.
Proficiency in Six Sigma methodologies and continuous improvement practices.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Industrial Machinery Manufacturing
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