Process Technology Manager
WhiteSwell Limited is developing medical devices for the treatment of Acute Decompensated Heart Failure (ADHF). The company is a fast growing and dynamic organisation and the company reserves the right to change the job description, role, and reporting structure to meet the evolving needs of the business.
Provide broad technical leadership and guidance to the business in the fields of materials science, surface modification, processing and process technology, electrochemistry, assembly, manufacturing and scaling operations.
Be a strategic partner and advisor to the VP of Technical Operations on chemical and process innovation, intellectual property as it relates to processing and manufacturing methodology, know-how, and Technical Operations core competency.
Drive the execution of the process development strategy in the business. Build capabilities, develop technical core competencies and ensure adherence to world class principles in the development and scaling processes of the business (design for manufacture, LEAN etc).
- Be the authority on all matters related to the chemistry, surface chemistry, and process technology of the group.
- Provide technical leadership and direction to the WhiteSwell senior management team on matters of surface chemistry, process engineering and the technological limitations of currently available solutions.
- Research and deliver complex process and development technologies to accelerate the next Generation of WhiteSwell devices to market.
- Build surface chemistry, process engineering, and world class manufacturing core competency in the business while supporting and delivering on project execution goals.
- Work closely with the R&D team to impart a deep understanding of the significant product and performance enhancements that can be achieved by electrochemical and polymer processing innovation.
- Build a state-of-the-art electrochemistry capability to advance proprietary and innovative surface treatment, characterisation, and improvement methodologies.
- Create an in-house research laboratory capability to advance coating and surface modification technology development, optimisation, and implementation.
- Play a leadership role in developing and managing pre-clinical in vitro and in-vivo device and device component evaluations to effectively measure performance across a complex array of design iterations.
- Foresee and manage technological risks in the business and promote the disciplines of risk management, project management and project execution in the Group.
- Identify and enhance product and process variables to maximize performance at prototype, lab/pilot, and full production stages.
- Develop fabrication processes on a lab-scale level necessary to prototype, sample, and evaluate biomaterials and/or related implants or devices.
- Plan and lead various stages of product development, including process development, optimization, scale-up studies and technology transfer to our OEM partners.
- Identify and evaluate competing processing and product technologies and determine whether WhiteSwell should build or leverage them into our supply chain.
- Plan, lead, and implement the development of complex pre and post processing of critical blood contacting components to position WhiteSwell as a global leader in the treatment of the ADHF patient population.
- Complete literature and patent searches to support product development and generate data/development reports for regulatory submissions or patent filings.
- Develop and implement an acute understanding of the blood material interface into the surface chemistry of all blood contacting elements of the WhiteSwell device to achieve best in class device antithrombogenicity.
Qualifications, Knowledge, Skills and Experience required:
- Masters or Ph.D. in Chemistry, Polymer Science, or a related discipline.
- Advanced knowledge of metallic and polymer chemistry and experience of delivering results through effective implementation of this knowledge.
- Excellent report writing and presentation skills.
- Brings support and positive attributes to a culture that is respectful, supportive, goal oriented, scientific, and diverse.
- Team player with an innovative mindset.
- Ability to read technical and clinical papers and present key findings in an easily comprehensible manner to groups with varying technical expertise.
- Strong driving force towards completion of tasks and driven to understand the disease state.
- Contributes to the success of the company’s products.
- Supports colleagues in the achievement of their strategic objectives.
- Provides leadership example to employees across the group.
- High integrity and honesty.
- The company is a fast growing and dynamic organisation and the company reserves the right to change the job description, role and reporting structure to meet the evolving needs of the business.
- Must be able to travel domestically and internationally by air and car and work occasional weekends. Must possess a valid driver’s license and passport.
- The executive is expected to develop and evolve his/her skills to stay abreast of the business and the evolving environment in which the business operates.