Job Description:
The role of this position will be responsible for leading process development and manufacturing engineering activities. This hybrid role will work in close conjunction with a supplier, requiring the successful candidate to work on-site with the supplier three days per week.
Main Responsibilities:
* Provide 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 NCMRs and CAPAs, supplier monitoring and audits, risk management, and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical devices 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 drive cost-saving initiatives.
Requirements:
* 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 and 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 organisational 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.