Senior Research And Development Engineer

Mentoring, coaching and development of team members if required.

Ensure compliance with Quality, Regulatory and company policies and systems.

Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.

The purpose of this role is to work as part of the Research and Development team in the design, development and taking to market of medical devices

• Work closely to build effective relationships with cross functional groups to achieve project and company goals.
• Manage device evaluations.
• Develop prototypes which are consistent with the clinical and design requirements of the project.
• Lead all key design decisions to ensure quality design selection.
• Project lead for assigned Research and Development team/s including technical and project management leadership responsibly.
• Research new therapies and design solutions to develop and complement the existing product portfolio.
• Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
• Project status communications and reporting.
• Generation of Design History File documentation.
• Introduce new equipment, materials and technologies.
• Design and/or process evaluation, reviews, specifications, verification and validation, protocols and reports and transfer to production activities in a timely and effective manner.
• Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
• Prototyping and test method design.
• Act as a designee for the Manager, Research and Development or Team Lead, Research and Development.
• Instrumental in driving and implementing change to improve departmental and company performance.
• Support other cross functional groups to deliver company goals.
• Support of regulatory submissions.
• Lead technical development of projects.
• Foster innovation and creativity within team and perform disclosure reviews.

• Bachelor’s degree required, preferably in engineering or a related field.
• Regular communication to cross-functional teams, senior management and business unit leaders.
• Compliance with Quality, Regulatory and company policies and systems.
• Strong statistical understanding and experience e.g. DOE and/or Gage R&R.
• Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards.
• Experience of medical device development from concept through to commercialisation.
• Experience in Product Development projects within Medical Device or regulated industry/adjacent experience.
• Proven experience working closely with project managers.
• Ability to effectively translate needs of clinicians and Strategic Business Unit into project inputs.
• Willingness and availability to travel on company business.
• Minimum of 5 years’ relevant experience is required.
• Good working knowledge of Solidworks and/or Pro Engineer CAD.
• Product and project risk analysis and risk management.

• Retrospective project reviews to understand lessons learned.