Senior Process Development Engineer
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.
Our Purpose
Our Galway based New Production Introduction teams focus on the development of cutting-edge medical devices in the Coronary, Structural Heart, PVH, Cardiac Rhythm Management and Neuromodulation space. Our Process Development Engineers are directly involved in working on the development of innovative products for use in medical procedures.
Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulation (SCS) to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat disorders such as Parkinson’s disease. We have gone on to develop the first implantable drug pump for the delivery of medication directly to the intrathecal space of the spine, inventing the first balloon kyphoplasty devices for the treatment of vertebral compression fractures and developing RF ablation systems to treat spinal tumors.
A Day in The Life Of:
Within Medtronic Neuromodulation, one key area of focus for reducing pain for patients is Interventional Pain. Interventional Pain develops minimally invasive therapies that treat musculoskeletal pathologies such as vertebral compression fractures, nerve pain, metastatic and benign bone tumors. The employee will be part of the Operations New Product Introduction team based in Minnesota and co-located with the R&D Team in Galway to define, develop and test new products for the Neuromodulation business.
Employee responsibilities may include the following:
- As a member of our team, you will actively participate in all areas of new product development including the following: Process design, Supplier selection, Sub Tier supplier management & Project management.
- Provide leadership to process development activities and Design transfer on multiple R&D projects.
- Effectively lead process development/validation activities with Contract Manufacturer to setup robust processes in place.
- Effectively lead process development activities with Medtronic Distribution centers to setup processes in place.
- Research technology solutions and collaborate with team members on Design, Reliability & Manufacturability methodology (DRM), utilize 3-D drawing/printing and Augmented Reality to develop our best solutions that will allow us manufacture devices that will positively impact the healthcare of millions.
- Collaborate with cross functional teams to define, execute and deliver on New Product Development requirements.
- Take initiative & lead a team to innovate and develop best in class process technology with emphasis on improving quality, reducing variation and developing state of the art automated and semi-automated systems.
- Lead and support the process development, characterization, and validation activities to support new product introduction.
- Identify and carry out practical actions to solve technical problems using your new and existing skills in project management, six sigma tools, process characterization and technology development.
- Collaborate, document, and present all learnings to project and functional teams.
- Participate in design and development activities like tolerance stack analysis, failure analysis, new risk (FMEAs etc)
- Represent manufacturability input on engineering drawings.
- Align on new/revalidation activities with the contract manufacturer
- Responsible for all the manufacturing and operation related activities like IQ/OQ/PQ, control plans, Co-suppliers documents and precision, MSA (inspection methods), AQL quantity, process flow, manufacturing protocols )
- DTP (design transfer plan)
- GQF127 (capture all the validation activities /control plans)
- DTC (design transfer confirmation)
- QAC ( quality assurance condition document)
- FAI (FAI at our contract manufacturing end)
- DMR (design of manufacturing records)
Key Skills & Experience
- Level 8 Degree in Engineering / Science or related discipline with minimum 4 years relevant direct engineering experience.
- We are looking for a self-driven engineer who can provide leadership to process development activities.
- Experience in Design transfer/Process Validation
- Experience working with contract manufacturers
- Experience in Design for Manufacturability assessment and early phase
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