R&D Design Engineer

Recruiter
Life Science Recruitment
Employment Type
Permanent
Salary
Not disclosed
Life Science Recruitment logo

NHL/ALCT-260444

R&D Design Engineer

Description

  • Develop & Deliver on new and exciting advanced drug delivery solutions as a Design Development Engineer on a cross-functional project team through all phases of the project lifecycle, from concept through launch.
  • Design, develop and verify complex products throughout the development life cycle.
  • Translate business requirements into a robust, scalable technical design.
  • Understand interactions between subassemblies in complex electromechanical systems, and design for high volume manufacturing for electro-mechanical medical devices.
  • Pursue complex problems by applying sound engineering principles, utilizing experimental, computational and analytical methods to a range of technical product development challenges.
  • Work closely with other R&D team functions, and external program functions to identify and mitigate technical issues to reduce programmatic risks.
  • Lead structured problem solving and root cause investigations.
  • Use predictive design and tolerance analysis techniques for calculation of design specifications.
  • Develop and test prototypes.
  • Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements such as ISO standards.

 

We are looking for a Design Development Engineer who can:

  • Work within multi-function teams comprising of QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members by facilitating effective communication and engagement.
  • Lead activities such as bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications.
  • Apply and assert DFSS best practices on all projects
  • Be an agile learner, tolerant of risk, and biased towards action
  • Effectively and clearly communicate concepts, ideas and knowledge to other individuals, teams and customers.
  • Ensure compliance with company quality policies, procedures and practices as well as with all local, state, federal and company safety laws, policies and procedures.

You will be effective if you have:

  • Experience in developing/launching medical products through a phase gate development cycle in an ISO13485 environment.
  • Demonstratable knowledge in related technical fields.
  • Excellent analytical skills & discipline; able to conduct thorough analysis of concepts that have high uncertainty
  • Intellectual drive to gain first hand understanding of customer needs and impact to requirements.
  • Excellent critical thinking skills; able to constructively challenge ideas and invite critical feedback.
  • Ability to engage with a diverse, multi-national team to achieve a common vision.
  • Ability to build relationships; demonstrated facilitation skills across different functions; motivated by collective success.
  • Communicator able to translate complex technical concepts for non-expert audiences.
  • History of working with functional and project managers to identify and mitigate technical issues to reduce programmatic risks.
  • A propensity to quickly learn new concepts and technologies and convert them into customer solutions.
  • The initiative to Identify innovation opportunities and drive continuous improvement efforts.

Minimum Qualifications:

  • Must have a Bachelor of Science Engineering or technical degree. A post graduate degree is desired.
  • Minimum of 3-5 years related work experience required (combination of work experience and advanced degrees), with related work experience in medical device development with an emphasis on wearable infusion pumps, large volume injection devices, or the like.
  • Experience in the selection and/or design and commercialization of parenteral drug delivery devices in the Biotech industry.
  • Proven track record of executing complex system designs incorporating mechanical subsystems, preferably in the medical device field
  • Experience in being part of multi-discipline engineering project teams
  • Must have strong verbal and written communication skills.
  • Proficiency with modern CAD, CAE and other design / simulation tools
  • Experience working in FDA regulated environment.
  • Willingness to travel (global) up to 10% of time.

 

Any applicant must have an existing work permit/ visa for Ireland. (Stamp 4 or EU passport)

Reach out to Niamh at Niamh.hlub or .