Our Client, a Leading Medical Device Multi-National in the Cork region, has Senior Engineer permanent position in the area of Process Validation/Development / Design / Project / Manufacturing Engineer roles in support of their R&D and NPI Department.
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Keltia is a technical support services company providing Engineering Design, CAD Training along with Specialized Technical Recruiting services to Irish industry and around the US, Canada and Europe. We have been in business in Ireland for over 9 years and in Seattle in the US for over 20 years.
Work Flexibility: Hybrid
You will support high visibility global manufacturing transfer projects on neurovascular components, spanning the full range of the neurovascular product line. This position will work with suppliers to develop new manufacturing processes for existing components and will work with the Stryker cross-functional team to qualify the components for use.
Job Roles & Responsibilities
- Independently research, design, develop, modify, and verify components, modules and sub-systems for medical devices. Translate user needs to design inputs/ specifications and produce complex system level de‐signs with some guidance.
- Conduct or design advanced prototyping and testing.
- Analyze and correct complex product design issues using independent judgment.
- Advance solutions by applying in-depth knowledge of customer needs, market and competitive offerings.
- Apply detailed knowledge of clinical procedures to author design inputs.
- Support Voice of Customer sessions internally and with clinicians.
- Demonstrate developing financial acumen.
- Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations.
- Lead creation and refinement of engineering documentation, such as the Design History file.
- Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System.
- Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
- Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.
- Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process.
- Deliver high quality results with passion, energy and drive to meet business priorities.
- Collaborate with cross-functional teams to build partnership to achieve business objectives.
Bachelor of Science in Engineering, Mechanical Engineering or Biomedical required
2+ years of engineering work experience required
Experience with engineering development, including IQ/OQ/PQ, and design verification & validation
A track record of contributing to successful medical device product introduction including at least one significant project from proof-of-concept through pilot production
Strong technical ability to develop and optimize designs for mechanical assemblies incorporating DFM principles
Strong technical ability in creating engineering drawings, models, applying GD&T
Adapt at applying knowledge of materials and manufacturing processes to product design.
Ability to communicate moderate complexity plans and technical information to team members.
Experience with design remediation
Experience with manufacturing transfers in a regulated industry
The ability to analyze complex situations, distill issues, develop insights, challenge the status quo, and synthesize recommendations
Work experience in medical device and/or biotech field, preferred
Knowledge of 21 CFR 820.30 - Design Controls and ISO 13485 section 7.3 - Design and Development, preferred
Please send a CV in Word .doc format with availability & pay requirements to firstname.lastname@example.org and we will get back to you immediately.