The role of Senior Staff Engineer takes on a hands-on, customer facing, technical leadership role on a cross functional project core team guiding the design, development, verification and validation of on-body combination products in support, this role will give the opportunity to develop user-centric on-body drug delivery solutions designed to drive patient empowerment, independence, compliance, and improved health outcomes.
Responsibilities:
* Be part of the team representing the organisation as one of the prime technical contacts to a pharma partner on a B2B product development project.
* Deliver on new and exciting advanced drug delivery solutions as a technical leader on a cross-functional project team through all phases of the project life-cycle, from concept through launch.
* Translate business requirements into a robust, scalable technical design.
* Pursue complex problems by applying sound engineering principles, utilising experimental, computational and analytic methods to a range of technical product development challenges over a range of products from simple disposable components to complex electromechanical and "smart" device assemblies.
* Work closely with both functional teams and project managers to identify and mitigate technical issues to reduce programmatic risks.
* Improve product development cycles and quality via the application of DFSS and Lean Product Development Tools
* Develop and guide technical design/methodologies to achieve product goals,
* Work within a team of R&D associates, applying best design practices, analysis, simulation and verification of subsystems and systems.
Technical Leader capable of:
* Representing R&D within a team of QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members by facilitating effective communication and engagement.
* Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, tolerance stack up analysis, FMEAs, design verification, validation, vendor interactions, materials specifications and component specifications.
* Demonstrate excellent interpersonal communication skills, which enable you to gain client trust and mentor junior engineers.
* 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 BD quality policies, procedures and practices as well as with all local, state, federal and BD safety laws, policies and procedures.
Requirements:
* BSc Engineering or technical degree.
* 5-8 years related work experience in medical device development with an emphasis on wearable infusion pumps, large volume injection devices, or the like.
* Must have strong verbal and written communication skills, including customer, and/or varying internal/external stakeholder interaction experience
* Deep experience in the selection and/or design and commercialisation 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
* Ability to lead multi-discipline engineering project teams
* Proficiency with modern CAD, CAE and other design / simulation tool
