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

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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

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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