Manufacturing Engineer
4 weeks ago
Manufacturing Engineer
The following information provides an overview of the skills, qualities, and qualifications needed for this role.
Interview process - 1 onsite interview with Travis (30-45 min) then will meet (30-45 min) and site tour.
EUMDR Special Project
The position will need to help execute gap assessments against EUMDR. So preferably candidates who are more familiar with that standard would be the preference. The individual should still have a strong validations background as well. After the gap assessment, the validations will take place.
Responsibilities:
Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices. Provide statistical analysis of the date to support the reports. Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.
Qualifications:
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma. Strong Project Management skills. Ability to lead teams through complex projects and provide departmental technical leadership. Must have excellent communication skills and a strong track record of working cross-functionally. Must have demonstrated ability to think strategically. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter.
Education and/or experience:
BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
Lean/Six Sigma Green or Black Belt Certification is a plus.
Experience in validations such as: manufacturing equipment, manufacturing processes, Test Method validation, stability or aging, required.
Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
Responsibilities:
Generate Gap Assessment for Design Files to EUMDR standard, including Validations, Labeling, Risk Files etc. Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices. Provide statistical analysis of the date to support the reports. Generation and implementation of change controls and engineering notices (ECO). Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary. Qualifications: Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma. Strong Project Management skills. Ability to lead teams through complex projects and provide departmental technical leadership. Must have excellent communication skills and a strong track record of working cross-functionally. Must have demonstrated ability to think strategically. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter. Education and/or experience: BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field. Lean/Six Sigma Green or Black Belt Certification is a plus. Experience in validations such as: manufacturing equipment, manufacturing processes, stability or aging, required. Minimum of 7+ years of experience in the medical device and/or pharmaceutical manufacturing environment.
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