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Senior Electrical Engineer, Combination Product Development

BioSpace · North Chicago, IL · 1 wk ago
EngineeringFull-time

About the role

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. This role involves leading electrical system design efforts for clinical development of advanced drug delivery systems, including on-body injectors, subcutaneous ambulatory infusion pumps, and other electromechanical systems.

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.

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

Qualifications

  • 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.

  • 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.

Key Stakeholders and Working Relationships

  • R&D team members (mechanical engineering, software engineering, systems engineering)
  • Regulatory and Quality Assurance functions
  • Operations and Supply Chain teams
  • Clinical and Commercial teams
  • External development partners
  • Project management and cross-functional leadership

Additional Information

  • Travel (domestic and/or international) may be required depending on project assignments (estimated 5%-10%).

  • This role requires strong attention to detail and commitment to quality and regulatory compliance.

  • The successful candidate will demonstrate a passion for advancing innovative drug delivery technologies.

Note

  • No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

  • The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

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