What are the responsibilities and job description for the Sr Process Engineer -only W2 - Medical Device position at Grove Technical Resources, INC?
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
