Principal Engineer | R&D

Daley And Associates, LLC.; Santa Clara (CA); On-site; USD 110,000 - 114,000; Full time

Benefits offered by this job

Up to 20% travel

Job summary

Daley And Associates, LLC. is seeking a Principal Engineer for a 6-month contract with potential extension in the biomedical devices field. The role blends technical leadership with hands-on lab work, including prototype development, device testing, and design verification.

You will manage timelines, coordinate with cross-functional teams, support design controls and regulatory requirements, and prepare reports for senior leadership. Travel up to 20% and competitive hourly pay of $80–$83.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related technical discipline.
• Minimum of 7 years of engineering experience in the medical device industry.
• Advanced CAD experience with SolidWorks.
• Hands-on device testing, prototyping, and fixture design experience.
• Working knowledge of FDA Quality System requirements, GMP, QMS, and international medical device regulations.
• Strong problem-solving and independent management of timelines and deliverables.
• Excellent written and verbal communication skills.

Responsibilities

• Lead R&D activities supporting new product development, product sustaining, and life-cycle management for disposable medical devices.
• Serve as the lead design engineer on projects of varying size, scope, and technical complexity.
• Perform hands-on device testing, troubleshooting, prototype development, and fixture design.
• Develop clinically relevant benchtop test models and methods to evaluate device performance.
• Create and execute test protocols and reports supporting feasibility, design verification, and product development activities.
• Analyze test data using appropriate statistical methods and communicate findings to cross-functional teams and senior leadership.
• Manage project scope, timelines, milestones, risks, budgets, and technical deliverables.
• Coordinate with Project Management and cross-functional partners to ensure projects remain on schedule.
• Support CAPAs, supplier change notifications, design changes, and other sustaining-engineering initiatives.
• Manage design-control activities and Design History File deliverables in compliance with internal procedures, FDA requirements, and international regulations.
• Partner with Manufacturing, Quality, and Regulatory teams to support products from concept through commercialization.
• Create samples for manufacturing, marketing, testing, and other project needs.
• Prepare technical reports, project updates, and presentations for senior leadership.
• Support lab-equipment maintenance, preventative maintenance, calibration, and IQ/OQ activities.
• Participate in preclinical product testing when required.

Job description

Principal Engineer | Reserach & Development

Our client, a global biomedical company focused on the development and commercialization of blood management products, is currently seeking a Principal Engineer to join their team for a 6-month contract with the potential to extend.

This person will serve as a lead design engineer supporting the development and life-cycle management of disposable medical devices. The role combines technical project leadership with substantial hands-on laboratory work, including prototype development, device testing, troubleshooting, test-method development, and preparation of technical reports.

The engineer will independently manage project timelines and deliverables while collaborating with Project Management, Manufacturing, Quality, Regulatory, and other cross-functional partners to keep programs moving forward.

Key Responsibilities

• Lead R&D activities supporting new product development, product sustaining, and life-cycle management for disposable medical devices.
• Serve as the lead design engineer on projects of varying size, scope, and technical complexity.
• Perform hands-on device testing, troubleshooting, prototype development, and fixture design.
• Develop clinically relevant benchtop test models and methods to evaluate device performance.
• Create and execute test protocols and reports supporting feasibility, design verification, and product development activities.
• Analyze test data using appropriate statistical methods and communicate findings to cross-functional teams and senior leadership.
• Manage project scope, timelines, milestones, risks, budgets, and technical deliverables.
• Coordinate with Project Management and cross-functional partners to ensure projects remain on schedule.
• Support CAPAs, supplier change notifications, design changes, and other sustaining-engineering initiatives.
• Manage design-control activities and Design History File deliverables in compliance with internal procedures, FDA requirements, and international regulations.
• Partner with Manufacturing, Quality, and Regulatory teams to support products from concept through commercialization.
• Create samples for manufacturing, marketing, testing, and other project needs.
• Prepare technical reports, project updates, and presentations for senior leadership.
• Support lab-equipment maintenance, preventative maintenance, calibration, and IQ/OQ activities.
• Participate in preclinical product testing when required.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering,
• Bioengineering, Industrial Engineering, or another relevant technical discipline.
• Minimum of 7 years of engineering experience within the medical device industry.
• Advanced CAD experience, including strong proficiency with SolidWorks.
• Hands-on experience with device testing, troubleshooting, prototype development, and fixture design.
• Working knowledge of medical device design controls and Design History File requirements.
• Experience developing and executing test protocols and documenting results.
• Familiarity with FDA Quality System requirements, GMP, QMS, and applicable international medical device regulations.
• Strong mechanical aptitude and practical problem-solving skills.
• Demonstrated ability to independently manage technical work, priorities, timelines, and project deliverables.
• Strong written, verbal, and presentation skills with the ability to communicate effectively across multiple functions and levels of an organization.

Preferred Background

• Experience designing, developing, or testing cardiovascular catheter delivery systems, vascular closure products, or comparable disposable medical devices.
• Experience with statistical study design and analysis, including DOE and ANOVA.
• Experience with IQ/OQ of laboratory equipment, preventative maintenance, and calibration.
• Experience supporting high-volume manufacturing environments.
• Experience with IDE, PMA, or Class III medical devices.
• Familiarity with Agile product-development practices.
• Experience interacting with customers or end users and translating customer needs into design requirements.

Travel

Up to 20%

Pay Rate

$80 - $83/hr

If you are interested in this position, please send your resume to [e-mail].