Senior Electrical Engineer, Combination Product Development

Sr. Electrical Engineer, Combination Product Development, R&D

We are seeking an experienced Sr. Electrical Engineer to support the development of innovative drug-device combination products within our Combination Product Development team in R&D. In this role, you will lead electrical system design efforts for clinical development of advanced drug delivery systems, including on-body injectors, subcutaneous ambulatory infusion pumps, and other electromechanical systems.

This role will contribute to the development of new device and platform technologies, maintaining technical rigor and ensuring compliance with regulatory standards. This role will work closely with engineering colleagues in R&D and cross-functional colleagues in a global organization as well as maintaining strong working relationships with external development partners throughout the product development process.

Responsibilities

Design and Development Leadership:

Work closely with external development partners through design and development efforts associated with electronic components of drug delivery systems

Execute feasibility and initial development activities including needs definition, requirements, assessment of design fundamentals, and technology landscaping

Conduct system architecture evaluation, including assessment of system design, testing, and analysis of electrical components

Perform electronics design assessments including circuit design, PCB assessment, circuit analysis, evaluation of design margins, and testing requirements definition

Technical Analysis and Validation:

Support system integration activities, reliability assessments, verification testing, and design validation to ensure products are technically robust and meet reliably goals

Provide engineering analysis and design history file documentation to support development activities, including Design Inputs, Design Outputs, Protocols, Task Analysis, and risk assessments

Support the lab and design verification teams with test plans, test setups, methods, investigations, and engineering confidence tests

Cross-Functional Collaboration:

Engage and collaborate with clinical, project development, regulatory, quality, and operations teams, as well as external engineering partners to ensure alignment throughout device development

Work across engineering disciplines (mechanical, software, systems engineering) to drive consensus and support execution on technical solutions

Partner with cross-functional stakeholders to ensure development deliverables and timelines meet regulatory standards and quality expectations

Professional Development and Process Improvement:

Establish and maintain working knowledge of technology trends and assess their relevance to combination product development

Partner with external vendors to understand and evaluate future technology roadmaps

Participate in and drive department continuous improvement initiatives focused on maximizing process efficiencies and enhanced collaboration

Use appropriate project management techniques and stage/gate processes to ensure successful completion of assigned projects

Education and Experience:

BS in Electrical Engineering or equivalent discipline, with typically 10+ years of relevant industry experience; MS in Electrical Engineering with typically 8+ years of relevant experience;

Demonstrated experience in medical devices or combination product development

Prior experience with subcutaneous injection devices, electromechanical devices, or digital/connected health technologies is highly desirable

Technical Skills and Knowledge:

Demonstrated expertise in electrical system design for drug delivery systems

Advanced understanding of circuit design, PCB design, and embedded systems; experience having designed and developed electrical systems from concept through product launch is a plus

Proficiency with design tools, simulation software, and analytical modeling techniques

Solid knowledge of applicable global regulatory requirements and industry standards (e.g., 21 CFR 820.30, ISO 13485, MDR)

Understanding of modern, lean product development methodologies and stage/gate processes

Experience with design verification and validation protocols in regulated environments

Competencies and Attributes:

Demonstrated ability to function as a technical leader, generating original technical ideas and development strategies

Possesses strong technical judgment and ability to work on problems of complex scope with competing factors

Excellent ability to work collaboratively with diverse groups within engineering and maintain strong working relationships with internal and external partners

Outstanding written and verbal communication skills with ability to clearly articulate technical challenges and solutions to stakeholders

Demonstrated project management capability and ability to balance multiple priorities

Proactive approach to identifying and resolving technical and project risks

Self-motivated with ability to operate independently

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