Lead the identification and development of new processing techniques for materials in medical devices, including implantable constructs, to overcome current materials and processing limitations.
- Develops technical solutions to complex technical problems where analysis of situations or data requires an in-depth evaluation of variable factors. Solutions may require the regular use of ingenuity and creativity.
- Assume the role of technical mentor for engineers in the function.
- Will monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
- May function in a technical leadership role on major programs.
- Develop a detailed understanding of “best practice” in product/process performance within the medical device industry.
- Develop a support network of key divisional/corporate leaders, academic and supplier partners to enhance understanding of product manufacturing and quality.
- Lead a culture of innovation within the function by developing and implementing engineering forums and reviews for the engineering team.
- Drive high levels of employee engagement through a highly effective support structure developed and implemented for all engineers.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
- All other duties as assigned.
- BS in Mechanical Engineering or related engineering discipline with 10 or more years’ experience; Related Masters’ degree with 6 or more years of experience; PhD with 2 or more years of experience may also be desirable.
- Ideal qualification will be materials science and Engineering or Mechanical Engineering with a strong experience in metallurgy.
- Experience in metallurgy, metals, alloys. Materials characterization or characterisation. Microsopy/microstructure. Phase identification.
- Experience with titanium, titanium alloys, CoCr or Stainless steel strongly desired.
- Mechanical testing and characterization (tensile strength, fatigue testing, fracture toughness)
- Porous metals experience desired
- Broad based business experience in high performance multi-national enterprise, at least 3 years of which has been spent in operations and/or technical leadership level in Medical Device or other highly regulated industries.
- Excellent Interpersonal Skills – able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.
- Strong capability to network and influence at all organisation levels
- Demonstrated project management and engineering expertise associated with new product introduction (NPI) in a regulated environment.
- Strong analytical ability with a high aptitude for understanding systems, gathering data and performing research.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Detailed understanding of the validation and verification process and its application relating to new products.
- Green or Black Belt 6 Sigma qualifications an advantage.
- High level of PC Skills required.
- Excellent attention to detail.
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email firstname.lastname@example.org