Process Development Leader

We are seeking an experienced Process Development Engineer to join our team. This role will be responsible for leading Process Development and Manufacturing Engineering activities.

Key Responsibilities:

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• Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts, as applicable.">
• Develop and Implement manufacturing capabilities using LEAN principles and tools including but not limited to Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis and Line Balance.">
• Responsible for working with Quality including management of NCMR's and CAPA's, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products.">
• Contribute to the successful execution of departmental and company goals.">
• Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.">
• Support business partners by providing technical leadership for company's long-term manufacturing and distribution channels.">
• Development and execution of commercial manufacturing timelines consistent with project and regulatory needs;">
• Financial modeling for COGS and scaling up production capacity.">
• Technology transfer to partner or contract manufacturing organizations, as applicable.">
• Promote and support a continuous improvement culture and drives cost saving initiatives.">
• Create and manage annual budget for Manufacturing project activities.">
• Provide strong integrity, vision, knowledge, and overall aptitude to the organization.">

The ideal candidate will have:

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• Bachelor's degree in engineering or related specialty with a minimum of 7 years' experience with at least 3 years in a technical leadership role in a biotechnology, pharmaceutical or medical device industry.">
• Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodology.">
• A proven track record in manufacturing and process development in a regulated environment. Medical device catheter product experience a plus.">
• Ability to achieve results in a virtual organisation. Experience working with cross-functional teams, project facilitation and demonstrated ability to complete projects on time.">
• This role is primarily technical in nature; thus, we seek someone who is passionate about Engineering concepts and principles - someone who gets a thrill from how and why things work.">
• A seasoned professional in manufacturing & engineering development with knowledge and skills in some or all of the following: DFM, technology evaluation, driving innovative solutions to complex problems, process design and development, materials (polymers and metals), design for six sigma principles, CAD (SolidWorks preferred), statistical techniques, process validation and control along with Manufacturing KPIs.">
• Excellent analytical and decision-making skills.">
• Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions.">
• Strong organizational, communication, interpersonal, managerial and leadership skills.">
• Ability to effectively and efficiently manage consultants, suppliers, vendors and budgets.">
• Ability to work in a fast paced, high growth environment. Ability to handle multiple tasks with high quality to meet Business timelines.">