Job Title: Senior Product Development Engineer
We are seeking a seasoned engineer to lead the development of complex medical devices. The successful candidate will be responsible for designing and implementing innovative solutions that meet regulatory requirements.
* Collaborate with cross-functional teams to develop product designs that ensure manufacturability and performance.
* Evaluate critical to quality requirements for components used in device construction and translate these requirements into component specifications.
* Assess new and existing suppliers for technical and manufacturing capabilities.
* Drive process/product improvements related to sub-assembly or component usage or design.
* Manage prototype builds to support characterization and develop assessment strategies.
* Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing line and pilot lines.
* Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place for components and finished devices.
* Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met.
* Monitor supplier performance and provide technical support to resolve issues.
* Implement changes under our change management system.
Required Skills and Qualifications:
At least 5-7 years of medical device medical process/device design and development experience in a regulated environment.
Desirable Experience: Prior experience in medical device catheter process design and/or manufacturing is highly desirable.
A strong understanding of product lifecycle and validation requirements for new product introduction is essential.
Experience in developing validation strategies for equipment or processes, including preparation of FMEAs protocols and reports, is also required.
Proficiency in structured problem-solving approaches (e.g. Six Sigma, DMAIC) is necessary.
Project Management experience, developing project schedules and managing resources and execution, is also required.
Design tools and practices expertise, including Design for Manufacture, Lean assembly, Solidworks, Prototyping and Test method development, is essential.
Excellent communication and interpersonal skills are required.
Benefits:
This role offers a competitive hourly rate.
The contract will run for 12 months.
We offer a positive work environment which respects diversity, supports wellbeing, and embraces innovation.