Device Design Leader / Associate Director

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 Associate Director, Device Design to join our Device Technology & Innovation team, with the focus on exploring, evaluating/de-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 drug delivery medical devices throughout their full life cycle.  This person will utilize their 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 is 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, or advanced degree (PhD or Master’s) and 5+ years' experience.
• Experience designing and development of medical device from early concept to launch phases, preferably in the drug delivery space.
• Extensive experience of 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.
• Experience in third party management (of manufacturers and vendors).
• Working experience of managing multiple projects of varying complexity simultaneously.

Preferred qualifications:

• Experience 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 mitigati