The Job
? You will be the Device Development SME and Technical Lead on
projects working with both the companies&#**Apply on the website**;
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&#**Apply on the website**;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
**Apply on the website**% travel, both domestic and global.
Requirements
? Bachelor&#**Apply on the website**;s Degree in Mechanical
Engineering, Biomedical Engineering, Engineering Technology or other
relevant Degree
? Over 8 Years&#**Apply on the website**; 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
Preferred Experience
? Thorough and proven knowledge Medical Device Directive (MDD), ISO
**Apply on the website**, 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)/
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval Location: Not Specified
The Job
? You will be the Device Development SME and Technical Lead on
projects working with both the companies&#**Apply on the website**;
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&#**Apply on the website**;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
**Apply on the website**% travel, both domestic and global.
Requirements
? Bachelor&#**Apply on the website**;s Degree in Mechanical
Engineering, Biomedical Engineering, Engineering Technology or other
relevant Degree
? Over 8 Years&#**Apply on the website**; 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
Preferred Experience
? Thorough and proven knowledge Medical Device Directive (MDD), ISO
**Apply on the website**, 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)/
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval
We need : English (Good)
Type: Permanent
Payment:
Category: Others
