Senior Process Engineer

3 weeks ago

Dublin, Dublin City, Ireland Boston Scientific Full time

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

We are seeking a Senior Process Engineer on a permanent basis to join our team.

Purpose:

Boston Scientific Clonmel is hiring a Senior Process Engineer to join its Process Development Team. This role will work cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of product into production.

Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Interfaces with Design, Quality and Manufacturing organizations to integrate new products, equipment sets or processes into production.

Responsibilities:

  • Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
  • Conducts feasibility studies to verify capability and functionality.
  • Develops new concepts from initial design to market release.
  • Writes and submits intellectual property (patents).
  • Maintains detailed documentation throughout all phases of development.
  • Working as part of the Process Development group, this person will aid design of new equipment for new products & manufacturing. This person will play a key role in the design phase of the equipment from initialization to final handover.
  • Works closely with machine vendors to ensure that the equipment is designed, built & tested according to Boston Scientific specifications and is properly handed over to manufacturing.
  • Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
  • Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
  • Plans, organizes, and conducts all aspects of technical reviews.
  • Ensures proper documentation is completed to meet quality systems requirements (e.g., BOM's, Routers, FMEA's, etc.).
  • Reviews or coordinates vendor activities to support development.
  • Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost-effective equipment and processes.
  • Demonstrates strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA's, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
  • Coordinates execution and documentation of validation builds, coordinates testing of validation units and the compilation, analysis and reporting of the validation results.
  • Demonstrates a primary commitment to patient safety and product quality.
  • Understands and complies with all the regulations governing the quality systems.
  • Experience with low-pressure dispense systems and injection moulding is an advantage.

Qualifications/Experience:

  • Hons bachelor's degree in engineering.
  • 5+ years engineering experience in a GMP environment.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

So, choosing a career with Boston Scientific isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

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