Senior Research & Development Engineer (MedSurg)
Senior Research & Development Engineer (MedSurg)
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Job Description
Overview
Reporting to: Team Lead Research and Development / Manager Research and
Responsibilities
Perform Duties of Senior Research and Development Engineer:
Design development
Prototyping and test method design.
Design and/or process evaluation reviews specifications verification andvalidation protocols and reports and transfer to production activities in atimely and effective manner.
Product and project risk analysis and risk management.
Develop prototypes which are consistent with the clinical and design requirements ofthe project.
Research new therapies and design solutions to develop and complement the existingproduct portfolio.
Introduce new equipment materials and technologies.
Generation of Design History File documentation.
Support of regulatory submissions.
Work closely with Key Opinion Leaders (KOLs) physicians and product managers todevelop innovative medical devices to improve patient care.
Project lead for assigned Research and Development team/s including technical and projectmanagement leadership responsibly.
Lead technical development of projects.
Lead all key design decisions to ensure quality design selection.
Manage the activities of the project team and drive project tasks to ensure timelycompletion of project milestones and business metrics are achieved.
Work closely to build effective relationships with cross functional groups to achieveproject and company goals.
Retrospective project reviews to understand lessons learned.
Manage device evaluations.
Compliance with Quality Regulatory and company policies and systems.
Mentoring coaching and development of team members if required.
Foster innovation and creativity within team and perform disclosure reviews.
Ensure compliance with Quality Regulatory and company policies and systems.
Communications:
Regular communication to cross-functional teams senior management and businessunit leaders.
Project status communications and reporting.
Remain on the forefront of emerging industry practices.
Instrumental in driving and implementing change to improve departmental and companyperformance.
Educating oneself in the medical area for which the new devices are being developed in orderto have an appreciation for what needs to be achieved with these products.
Support other cross functional groups to deliver company goals.
Act as a designee for the Manager Research and Development or Team Lead Research andDevelopment.
Ensure that Cooks Code of Conduct is considered in all business matters carried out onCooks behalf
Qualifications
- Bachelors degree required preferably in engineering or a related field.
- Minimum of 5 years relevant experience is required.
- Experience in Product Development projects within Medical Device or regulatedindustry/adjacent experience.
- Proven project/technical experience.
- Project management methodology and skills.
- Proven experience working closely with project managers.
- Knowledge of medical device quality standards ISO13485/FDA practices EUMDR GMPand similar regulated industry standards.
- Strong statistical understanding and experience e.g. DOE and/or Gage R&R.
- Strong technical writer.
- Good working knowledge of Solidworks and/or Pro Engineer CAD.
- Experience of medical device development from concept through to commercialisation.
- Ability to effectively translate needs of clinicians and Strategic Business Unit into projectinputs.
- Willingness and availability to travel on company business
About Cook Limerick
Cook Medical has been in Limerick since 1996 starting out with labeling and distribution and steadily growing and evolving to include manufacturing centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cooks products for global markets.
Research and Development in Limerick
Our mission with R&D is to invent manufacture and deliver a unique portfolio of medical devices to the healthcare systems of the world.
Our R&D team in Limerick is split into two divisions Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch.
The MedSurg R&D team in Limerick has two programs Endoscopy/EndoSurgery and Otolaryngology Head and Neck Surgery (OHNS) that it is responsible for designing and developing new and innovative products for. The R&D engineers and scientists have the opportunity to explore and create novel ideas within feasibility bring a medical device through verification and validation phase and be a part of bringing a new product to the market. The MedSurg R&D team works in collaboration with Cooks sister site in Winston Salem North Carolina.
Our employee benefits include:
- Hybrid Work Model
- Company sponsored Defined Contribution pension scheme
- Medical Health Insurance cover for you and your immediate family
- Life Assurance and Income Protection cover
- Educational Assistance
- Performance related Bonus
- Extensive health & wellness program including Indian head massages healthy lifestyle seminars mindfulness courses physio sessions flu vaccinations nutrition talks
- Fully equipped gym on site
- 39-hour week with flexible start & finish times
- Paid time off to participate in volunteer activities
- Free parking
- Subsidised restaurant
- Sports & Social club
#LI-Hybrid
Required Experience:
Senior IC
Employment Type
Contract
