Sr Process Engineer
4380 Swinnea Road Memphis, TN 38118 US
Job Description
A Day in the Life
In this exciting role as a Process Engineer, you will be responsible for developing and supporting production processes that may include software loading, testing, assembly, kitting, and packaging operations. The position will also coordinate the introduction of new products and processes to the production floor ensuring the timely introduction of capable and proven processes.
The employee will be part of the Operations New Product Introduction team based in Minnesota and co-located with the Manufacturing Team in Memphis to define, develop and test new products for the Neuromodulation business.
In this role, responsibilities may include:
- 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 the 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.
Must Have (Minimum Requirements)
- 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
Nice to Have
- 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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