Senior Process Development Engineer
Job ID: JOB-13064
Senior Process Development Engineer
The primary purpose of this position is to lead a team of Engineers focused on the development of processes required to manufacture device designs which are developed by Research & Development in this Medical Device Company.
Reporting to Research & Development Manager
- Lead a team of Engineers focused on identification, development, and implementation of new processes required for the manufacture of device designs which are developed by R&D in the company.
- Ensure that a risk based approach is applied during the development implementation and validation of all processes both within the Medical premises and with third party suppliers.
- Ensuring that the principle of Design for Manufacture is central to the R&D process and the devices developed within R&D.
- Where appropriate apply Lean Manufacturing principles to the design and implementation of new processes.
- Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role.
- Work with the R&D Manager and other Senior Engineers to ensure the appropriate allocation of resources and prioritization of efforts for the overall R&D group.
- Collaborate with other R&D Teams to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
- Ensure effective reporting to the R&D Manager.
- Work closely to build effective relationships with other functions in particular Operations, Quality and Regulatory teams.
- Supplier selection, process development and validation.
- Support Regulatory Affairs as required with engineering input for process related submissions and renewals prior to and post initial release of devices to market. Ensure the effective transfer of products from other entities.
- Provide engineering input and support to those responsible for Supplier instigated changes.
- Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
- Responsible for process engineering layout plans and implementation in relation to new processes and production lines.
- Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market.
- Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
- Drive the compliance culture amongst Manufacturing Engineering team members and ensure that compliance requirements are always met. Liaise with other manufacturing facilities. Support other cross functional groups to achieve company goals.
- Benchmark systems and processes against best industry practice, modify and develop accordingly to further improve operational efficiencies. Delegate for Manufacturing Engineering Manager/ R&D Manager and Senior Test Engineer. Ensure that Code of Conduct is considered in all business matters carried out on their behalf.
- Qualifications: Formal Production/Engineering qualification and relevant experience in the area of NPI and/ or process development
- Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff. Proven project management capability in a project leader role.
- Strong interpersonal skills and the ability to communicate at all levels of the organization. Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
- Proven problem-solving skills. Good computer skills including knowledge of Microsoft® Office. Excellent organizational and team building skills.
- High self-motivation. Willingness and availability to travel on company business.
- We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.
- Our client has been in Limerick since 1993. Since opening, we have become a European headquarters for many of our clients business functions. With a global workforce of over 12,000, we employ over 950 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialization.
- 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. Serving patients is a privilege, and we demand the highest standards of quality, ethics, and service in all that we do. 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 R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies.
- The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be apart of bringing a new product onto the market.
All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies.
Our employee benefits include:
- Hybrid working – mix of remote & onsite
- 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
- Subsidized restaurant Sports & Social club.
For further information on this role in please contact on Shauna Brady on 086-441 0614 or firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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Senior Process Development Engineer
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