Manufacturing Engineer II

Duration: 9 Months (40hrs/weeks)

Must have knowledge and understanding in new EUMDR regulations. Ability to conduct a gap analysis for site manufacturing processes/documentation and the new EUMDR regulations. Ability to project manage all changes related to EUMDR at the site level. Generation and implementation of change controls and engineering notices (ECO). 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.

Qualifications: Knowledge of EUMDR, 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 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.

Shift: M-Friday, 1st Shift