Job Description

Job Title - Sr Process Engineer - Exempt

Job Location - Memphis, Tennessee

Duration: 12 Months

Job Description -

• Process Development, including characterization, process and equipment qualification, validation activities
• Problem solving – demonstrated ability to resolve production issues
• Manufacturing and quality experience: Able to partner with operations and quality to develop manufacturing methods and work instructions
• Years’ Experience Required: 4 years+
• Development of device processing, assembly and packaging methods for assigned product lines.
• Proactively execute and support validation/qualifications activities (e.g. IQ, OQ, PQ, Characterization)
• Partner with Quality Engineering to ensure proper process compliance, including quality documentation (e.g. work instruction, quality system reports, etc.)
• Partner with Quality during risk management activities. May lead and/or actively participate in risk management documents review, e.g. Design and Process Failure Mode and Effects Analysis
• Resolve technical production problems on assigned product lines in finishing and assembly and packaging operations working with shop employees and quality personnel.
• Collaborate cross-functionally to develop new line layout and infrastructure to support assigned products. May make recommendations to management on plant layout.
• May recommend and implement manufacturing equipment acquisitions. Work with equipment suppliers on equipment specifications, quoting of specified equipment and delivery schedules.
• Initiate and direct improvements in current manufacturing methods and processes to improve quality performance, process efficiency, and to reduce manufacturing costs
• May lead in the training of direct and indirect team members
• Ensure processes and procedures are in compliance with regulations (21 CFR 820) and Medtronic Quality Systems.
• Provide periodic updates of assigned projects to senior management, maintain project documentation, project plans, action item registers and actively manage risks related to cost, quality and schedule.
• Performs other duties as assigned.
• Bachelor’s degree in engineering, science or related discipline with minimum 4 years relevant experience.
• Experience in Process Development, including characterization, process and equipment qualification, and validation activities
• Experience in quality documentation activities within highly regulated environments
• Excellent Communication skills, both written and verbal
• Ability to collaborate cross-functionally
• Medical device industry experience.
• Experience in Design Transfer
• Experience supporting various equipment, including testing, firmware or software loading, and related processes
• Experience working with Manufacturing Execution Systems
• DRM and/or Lean Six Sigma Certification

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