Principal Device Design Engineer

About the Role

GSK's Packaging, Device and Design Solution (PDDS) organization is charged with the delivery of robust, patient-centric devices and primary packaging solutions to enable the effective delivery of novel pharmaceuticals across all modalities and routes of administration. Our organization is a multi-skilled team of Engineers, Scientists and Designers who work across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection, development, ultimately, the registrational submission and commercial supply.

We are seeking a Principal Device Design Engineer to join our Device Technology & Innovation team, with the focus on exploring, evaluating/re-risking, and final selecting of next-wave drug delivery technologies to support GSK's near-term pipelines and long-term device strategies.

The ideal candidate shall be a technical expert who has experience of leading the design and development of medical devices throughout their full life cycle. This person will utilize his/her extensive product design experience to lead technical assessment and evaluation of new medical device technologies under GSK's consideration utilizing a wide variety of engineering principles and play an important role of ensuring GSK's next generation medical devices and combination products to meet their functional performance, reliability and safety standards.

Following successful candidacy, you will join a dynamic and growing team that are key to delivering an expanding portfolio. The role is based at either of GSK's R&D sites in Upper Providence, Pennsylvania (US) or Waltham, Massachusetts (US) and can offer flexible hybrid working. Occasional travel may also be required.

Key responsibilities

• Provide technical leadership to support early device development projects while engaging with Early Engagement and Device-ability, Device Engineering, Primary Packaging, Formulation and Patient insight Subject Matter Experts (SMEs).
• Lead and support device technology landscaping evaluations.
• Lead targeted device technology design, capability and robustness assessment in partnership with device and product development colleagues; identify and mitigate risks associated with device functionality, reliability, safety, COGs and manufacturing scalability.
• Lead strategy and execution of feasibility and engineering confidence tests to determine new device design viability and margin, alongside with computation modelling and simulation.
• Liaise with our internal and external manufacturing partners to assess early technology device Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Thoroughly document and communicate results through authorship of technical memos, reports and presentations.
• Help drive an internal culture of innovation, including developing and curating a portfolio of problem statements across the portfolio, leading structured ideation sessions, and encouraging creativity.
• Maintain visibility as a sought-out expert in the field, through regular attendance at internal and external symposia, presentations, and/or via publications.
• Collaborate with external companies/vendors, maintaining and building strong relationships with key partners.

Why You

Basic qualifications:

• Bachelor's degree in mechanical engineering, biomedical engineering, or other similar discipline and 10+ years' relevant experience..
• Experience with using CAD (Solidworks), simulation software, and statistical analysis.
• Expertise around regulatory requirements for parenteral combination products (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366).
• Experience in prototyping, testing, and evaluating mechanical designs.
• Strong background in third party management (of manufacturers and vendors).
• Experience of managing multiple projects of varying complexity simultaneously.

Preferred qualifications:

• Master's degree and 5+ years' experience.
• Experience in designing and development of medical device from early concept to launch phases, preferably in the drug delivery space
• A proven track record of solving challenging problems, innovating and building and cultivating a culture of innovation.
• An extensive experience of medical device new concept generation, optimization, and industrialization, preferably for drug delivery system.
• In depth knowledge of the US/EU external device-mediated drug delivery technology innovation ecosystem.
• Comfort with hands-on problem solving and rapid prototyping.
• Facility with use of technology for data and information management.
• A keen eye for identifying project risks and proactively developing mitigation plans

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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