Staff R&D Engineer

SoloPoint Solutions, Inc.; Pleasanton (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

SoloPoint Solutions, Inc. in Pleasanton, CA, is seeking an accomplished mechanical/biomedical engineer with 10+ years of medical device experience to lead design and development of single-use devices and accessories.

The role requires hands-on problem solving, root cause analysis, and a track record delivering concepts to commercialization in regulated environments. Collaboration with cross-functional teams is essential.

Qualifications

• Bachelor's in Mechanical Engineering, Biomedical Engineering, or related field with 10+ years of medical device experience, or an advanced degree with 9+ years.
• Proven track record taking designs from concept through commercialization, applying DFX principles to scale.
• Design expertise in two or more of: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics.
• Proficiency in SolidWorks, design for manufacturability, tolerance stack analysis, and GD&T.
• Experience with design of experiments (DOEs) and statistical data analysis; simulation experience (CFD, FEA) a plus.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820, plus sterilization and biocompatibility testing in a regulated industry.
• Experience leading technical teams and mentoring engineers.
• Strong collaboration, communication, and hands-on problem-solving skills; must comply with applicable vaccination requirements.

Responsibilities

• Lead design and development of new single-use devices and accessories, serving as technical lead and, when needed, core team lead.
• Keep all design work compliant with design controls, partnering cross-functionally to ensure manufacturability, reliability, and scalability.
• Build prototypes, design fixtures, run feasibility studies, and execute testing to guide product decisions.
• Solve engineering problems through root cause analysis and data-driven methods.
• Define and lead qualification strategies for new designs and processes, aligning with teams across the organization.
• Translate customer needs into product requirements and engineering specifications.
• Develop test methods, write and execute protocols, and author reports and risk documentation.
• Manage suppliers and coordinate external sterilization, packaging, and biocompatibility testing; communicate progress, results, and risks to stakeholders.

Education

Bachelor's in Mechanical Engineering or Biomedical Engineering

Advanced degree in related field

Tools

SolidWorks

Tolerance stack analysis

GD&T

Design for Manufacturability

DOE

CFD

FEA

Job description

Qualifications

• Bachelor's in Mechanical Engineering, Biomedical Engineering, or a related field with 10+ years of medical device experience, or an advanced degree with 9+ years
• Proven track record taking designs from concept through commercialization, applying DFX principles to scale
• Design expertise in two or more of: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics
• Proficiency in SolidWorks, design for manufacturability, tolerance stack analysis, and GD&T
• Experience with design of experiments (DOEs) and statistical data analysis; simulation experience (CFD, FEA) a plus
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820, plus sterilization and biocompatibility testing in a regulated industry
• Experience leading technical teams and mentoring engineers
• Strong collaboration, communication, and hands-on problem-solving skills; must comply with applicable vaccination requirements

Responsibilities

• Lead design and development of new single-use devices and accessories, serving as technical lead and, when needed, core team lead
• Keep all design work compliant with design controls, partnering cross-functionally to ensure manufacturability, reliability, and scalability
• Build prototypes, design fixtures, run feasibility studies, and execute testing to guide product decisions
• Solve engineering problems through root cause analysis and data-driven methods
• Define and lead qualification strategies for new designs and processes, aligning with teams across the organization
• Translate customer needs into product requirements and engineering specifications
• Develop test methods, write and execute protocols, and author reports and risk documentation
• Manage suppliers and coordinate external sterilization, packaging, and biocompatibility testing; communicate progress, results, and risks to stakeholders