Principal R&D Engineering - Exploratory jobs in United States
cer-icon
Apply on Employer Site
company-logo

Bolt Medical · 2 months ago

Principal R&D Engineering - Exploratory

Bolt Medical is focused on early stage medical device development, and they are seeking a Principal R&D Engineer to contribute to exploratory programs. The role involves developing new technologies, managing multiple projects, and collaborating with suppliers to address unmet medical device needs.

ManufacturingMedicalMedical Device
check
H1B Sponsor Likelynote
Hiring Manager
Dania Cital
linkedin

Responsibilities

Utilize research and experience to develop new technologies to improve therapies of medical devices
Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives
Work independently to develop high value IP to solve unmet medical device needs for existing or new therapies
Collaborate with external suppliers for components and identify outsourcing opportunities to accelerate early development cycles
Understand the technology and key product features that ensure clinical and commercial success
Manage research and development activities for exploratory phase of a project
Make data driven decisions using appropriate analytical methodologies
Prepare for and conduct various exploratory concept reviews
Demonstrate deep insight regarding design intent and use insight to drive value added early-stage design ideas
Working with highly skilled technicians, develop processes necessary to fabricate devices
Develop and implement new test methods to assess performance characteristics of designs
Prepare documentation to support design transfer for early development teams. (IP, concept documents, test results, drawings, etc.)
Provide technical leadership along with technical subject matter expertise to technology development team during exploratory design transfer
Research and recommend material choices for product designs
Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders
Utilize research and experience to develop new technologies to improve therapies of medical devices
Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives
Work independently to develop high value IP to solve unmet medical device needs for existing or new therapies
Collaborate with external suppliers for components and identify outsourcing opportunities to accelerate early development cycles
Understand the technology and key product features that ensure clinical and commercial success
Manage research and development activities for exploratory phase of a project
Make data driven decisions using appropriate analytical methodologies
Prepare for and conduct various exploratory concept reviews
Demonstrate deep insight regarding design intent and use insight to drive value added early-stage design ideas
Working with highly skilled technicians, develop processes necessary to fabricate devices
Develop and implement new test methods to assess performance characteristics of designs
Prepare documentation to support design transfer for early development teams. (IP, concept documents, test results, drawings, etc.)
Provide technical leadership along with technical subject matter expertise to technology development team during exploratory design transfer
Research and recommend material choices for product designs
Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders

Qualification

Medical device engineeringBalloon catheter developmentCAD software (SolidWorks)IP generationPatentsMechanical design principlesFDA class 3 devicesStatistical analysis (Minitab)Quality systems FDA QSRQuality systems ISO 13485Leadership skillsInterpersonal skillsProblem-solving skills

Required

BS degree in Engineering, Biomedical or Physics
Minimum of 15 years of experience in medical device engineering
Proven track record of developing medical devices from concept to design transfer that have made it to market
Generated core IP and patents related to commercial medical devices
Proficient in CAD software, preferably SolidWorks
Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD)
Excellent hands-on mechanical prototyping, verification, and failure analysis skills
Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results

Preferred

MS/PHD in Engineering, Biomedical or Physics
Polymer knowledge along with extrusion, injection molding experience and metallurgy
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
Working knowledge of mechanical design principles
Experience developing FDA class 3 medical devices
Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred
Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred
Knowledge of ASME Y14.5 GD&T
A flexible team player, focusing on shared goals with a positive results‐oriented attitude
Strong leadership skills and mentoring capabilities
Strong interpersonal and communication skills (oral/presentation and written)
Strong quantitative analysis and problem-solving skills and methodologies

Company

Bolt Medical

twittertwittertwitter
company-logo
Bolt Medical develops medical devices like the investigational Bolt IVLTM System, focusing on healthcare solutions.

H1B Sponsorship

Bolt Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (1)
2021 (1)

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
Boston Scientific
2025-01-08Acquired
2019-01-01Corporate Round
Company data provided by crunchbase