Role: Manufacturing Engineer II
Duration: 12 Months
Responsibilities:
Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and manufacturing to maintain and improve surgical products.
Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Responsible for identifying acceptance criteria for product specifications.
Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
Provide engineering knowledge and resolve design, manufacturing, and quality-related problems impacting existing products.
Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.
Ability to adjust priorities when with shifting business needs.
Support manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
Provide project leadership to improve existing products and associated manufacturing processes.
Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
Support corrective actions and the implementation of all corrective actions to ensure improvements are attained.
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 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
Controlled regulated industry
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