Highly Technical Process Engineering Role
We seek an experienced Process Development Engineer with expertise in leading manufacturing transfer and developing manufacturing capabilities using LEAN principles.
* Key Responsibilities:
* Provide technical leadership for the transfer of new products and changes to existing products, ensuring smooth transition using design for manufacturability concepts.
* Develop and implement manufacturing processes utilizing LEAN methodologies.
* Collaborate with Quality on non-conforming material reports (NCMR's), corrective actions (CAPA's), supplier monitoring, audits, risk management, and internal controls while ensuring compliance with ISO 13485 standards.
* Contribute to departmental goals by providing regular updates to stakeholders on objectives, projects, and performance metrics.
* Support business partners through technical leadership for long-term manufacturing and distribution strategies.
* Lead the development and execution of commercial manufacturing timelines and financial modeling for cost of goods sold (COGS) and scaling up production capacity.
* Transfer technology to partner or contract manufacturing organizations.
* Promote a culture of continuous improvement and drive cost-saving initiatives.
Requirements
* Bachelor's degree in engineering or a related field with a minimum of 7 years' experience, including at least 3 years in a technical leadership role in biotechnology, pharmaceuticals, or medical devices.
* Experience working within ISO 13485 regulated quality systems and a proven track record in manufacturing and process development in a regulated environment.
* Strong analytical and decision-making skills, with excellent organizational, communication, interpersonal, managerial, and leadership abilities.