Senior R&D Engineer
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Job Location:
Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Senior R&D Engineer Job Overview
The Senior R&D Engineer leads end-to-end product development working with cross-functional teams to identify unmet clinical needs develop innovative concepts and guide solutions from idea through launch. This is a remote role with occasional required visits to company and customer sites. Candidates located within approximately two hours of Lincolnshire IL are preferred.
Key Responsibilities
The Senior R&D Engineer leads end-to-end product development working with cross-functional teams to identify unmet clinical needs develop innovative concepts and guide solutions from idea through launch. This is a remote role with occasional required visits to company and customer sites. Candidates located within approximately two hours of Lincolnshire IL are preferred.
Key Responsibilities
- Identify unmet customer needs in acute and hospital-based clinical environments.
- Conduct research on clinical workflows procedures equipment and emerging trends.
- Lead Voice of Customer activities including planning data collection and analysis.
- Observe healthcare environments and synthesize insights into opportunities.
- Develop and refine product concepts features and prototypes.
- Evaluate materials production methods costs and feasibility.
- Translate insights into user needs requirements and design specifications.
- Lead cross-functional teams through full design development and launch.
- Manage project plans communication documentation and design controls.
- Ensure compliance with FDA Design Controls ISO 13485 and ISO 14971.
- Collaborate with external partners such as design firms testing labs and consultants.
- BS in Engineering (Mechanical Biomedical or Materials preferred).
- 5 years of experience developing medical devices or comparable regulated products.
- Strong understanding of FDA 21 CFR 820.30 ISO 13485 and risk management principles.
- VOC experience and product research
- Proficiency in concept development prototyping usability engineering and user-centered design.
- Strong analytical problem-solving and communication skills.
- Demonstrated ability to lead cross-functional projects and influence stakeholders.
- Familiarity with CAD tools (AutoCAD Pro/E or SolidWorks).
- Basic understanding of budgeting cost estimation and forecasting.
- Self-motivated collaborative and able to work independently.
- Proficient in Microsoft Office and Teams.
- Ability to travel (up to 15%) and meet healthcare credentialing requirements.
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
