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