You will be the Device Development SME and Technical Lead on projects working with both the companies’ portfolio of Legacy Products (which is continually expanding through high profile acquisitions) and NPD.
You will lead or participate in the design and development activities of Medical Devices and Combination Products through the design lifecycle from Concept to Commercialization.
Working with Key Stakeholders, Senior Management and External Partners to ensure technical requirements are achieved
Develop an understanding of Customer Needs and processes to ensure relevant and innovative product development solutions
You will define and review Tolerance Stack-Up Analysis for complex mechanical assemblies
Drive Root Cause Investigations and provide guidance for FEA Analysis and in Interpreting Results
Lead development of appropriate Test Plans to fully characterize devices under development
Conduct Design Reviews, FMEA's and Design Verification programs
Prepare Technical Files and update documents including product specifications, DHF, drawings, bill of materials, study protocols and supporting design verification activities
Manage and assess External Vendors/supplier work and capabilities
Support Design Validation and Process Validation programs and lead reviews of any anomalies related to mechanical performance
Support Regulatory Submissions and approvals for combination product programs
Support Post Approval Regulatory Submission for market expansion and timely technical responses to FDA and healthcare authority inquiries
Lead technical aspects of Product Design Change to support quality closures, engaging with medical affairs, supply chain, quality, regulatory, packaging and R&D teams to gather and incorporate inputs for managing marketed product changes
Collaborate with R&D, supply chain, and commercial team to Develop Drug Delivery Devices for pipeline products and to provide post launch market support globally
You will be working with groups in different geographical regions on a regular basis, e.g., early and late conference calls with circa 10% travel, both domestic and global.
Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Engineering Technology or other relevant Degree
Over 8 Years’ Experience in the Development and Registration (up to commercialization) of Drug Delivery Devices and Medical Devices
You will need to be a Strong Communicator to work well with other engineers in a collaborative, fast-paced goal-driven environment
Experience of working with GMP, international device regulations and design controls, with practical understanding of key topics: risk management, sterilization, usability
Thorough and proven knowledge Medical Device Directive (MDD), ISO 13485, FDA Design Controls or similar regulatory environment
Strong Materials Background, particularly in plastics and manufacturing of plastic components
Extensive experience with Solidworks or other CAD software
For further information on this Principal Mechanical Engineer role in Dublin please contact Amanda Reynolds on (phone number removed)/ email@example.com
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