Senior Manufacturing Engineer

Overview

WhiteSwell 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.

Position Summary

Reporting to the VP of Technical Operations, provide broad technical leadership and guidance to the business in the fields of processing and process technology, assembly, manufacturing, and scaling operations. Drive the execution of the technical operations 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 & Assembly, LEAN etc).

Responsibilities

  • Research and deliver complex process and development technologies to accelerate the next generation of WhiteSwell devices to market.
  • Identify, evaluate, manage, and provide technical guidance to suppliers, including establishing tolerances and defining acceptance criteria related to materials, manufacturing processes, and design.
  • Lead design to manufacturing transfer activities.
  • Build world class process engineering and manufacturing core competencies in the business while supporting and delivering on project execution goals.
  • Identify and enhance product and process variables to maximize performance at prototype, pilot, and production stages.
  • Detailed project planning and leadership of 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.
  • Implement DFM and DFA principles into the design and development process at WhiteSwell.
  • Evaluate, with the R&D team, the design and supply chain risks in the project and develop strategies to highlight, monitor, manage and mitigate these risks.
  • Oversee and implement component, process, test, and design validation methodologies, protocols and reports.
  • Ensure that high quality product is delivered, and that the supply chain runs smoothly and efficiently.
  • Utilize Lean Manufacturing tools, troubleshooting, and problem solving methods.
  • Develop and implement manufacturing build plans with subcontract manufacturers to meet demand.
  • Manage external relationships with technology and component providers.

Knowledge and skills required

  • Bachelor’s degree in Biomedical, Mechanical, Polymer, Materials, or Industrial Engineering. A Masters or PhD in a related field is highly desirable, or an equivalent combination of education and technical experience.
  • 5+ years of engineering experience working for a MedTech company whose products and processes are FDA regulated.
  • Experience in the development and production of medical devices that require complex processes and assembly techniques and a proven ability to deliver results in this setting.
  • Holds him/ herself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
  • A self-starter who can see and deliver the entire program of work required to realize the business strategy with a minimal amount of direction.
  • 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.
  • Supports colleagues in the achievement of their strategic objectives.
  • Provides leadership example to employees across the group.
  • High integrity and honesty.

General

  • 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 Senior Manufacturing Engineer is expected to develop and evolve his/ her skills to stay abreast of the business and the evolving environment in which the business operates.