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 of this role, there will be opportunities to develop user-centric on-body drug delivery solutions designed to drive patient empowerment, independence, compliance, and improved health outcomes.
Responsibilities:
1. 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.
2. 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.
3. Translate business requirements into a robust, scalable technical design.
4. 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.
5. Work closely with both functional teams and project managers to identify and mitigate technical issues to reduce programmatic risks.
6. Improve product development cycles and quality via the application of DFSS and Lean Product Development Tools.
7. Develop and guide technical design/methodologies to achieve product goals.
8. Work within a team of R&D associates, applying best design practices, analysis, simulation, and verification of subsystems and systems.
Technical Leader capable of:
1. Representing R&D within a team of QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members by facilitating effective communication and engagement.
2. Mentoring and motivating 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.
3. Demonstrating excellent interpersonal communication skills, which enable you to gain client trust and mentor junior engineers.
4. Being an agile learner, tolerant of risk, and biased towards action.
5. Effectively and clearly communicating concepts, ideas, and knowledge to other individuals, teams, and customers.
6. Ensuring compliance with BD quality policies, procedures, and practices as well as with all local, state, federal, and BD safety laws, policies, and procedures.
Requirements:
1. BSc Engineering or technical degree.
2. 5-8 years related work experience in medical device development with an emphasis on wearable infusion pumps, large volume injection devices, or the like.
3. Must have strong verbal and written communication skills, including customer and/or varying internal/external stakeholder interaction experience.
4. Deep experience in the selection and/or design and commercialization of parenteral drug delivery devices in the Biotech industry.
5. Proven track record of executing complex system designs incorporating mechanical subsystems, preferably in the medical device field.
6. Ability to lead multi-discipline engineering project teams.
7. Proficiency with modern CAD, CAE, and other design/simulation tools.
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