Senior Mechanical Engineer - Medical Devices Design

Stark Pharma Solutions Inc; Fremont (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Mechanical Engineer to support medical device product development, testing, troubleshooting and mechanical design in a regulated environment.

Focus areas include disposable devices, prototype development, design controls and cross-functional collaboration. The role requires 7+ years in medical devices, SolidWorks prowess, fixture design, and comprehensive knowledge of FDA/GMP/QMS requirements.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 7+ years of experience in the medical device industry.
• SolidWorks and mechanical design experience.
• Fixture design and prototype development experience.
• Hands-on device testing and troubleshooting.
• Knowledge of medical device design controls.
• Experience with Design History Files and quality systems.
• Experience with IQ/OQ, preventive maintenance, and equipment calibration.
• Knowledge of DOE, ANOVA, and statistical study methods.
• Experience with design verification and validation.
• Knowledge of FDA and international medical device regulations.
• Experience with GMP and QMS requirements.
• Cardiovascular catheter or delivery system experience is a plus.
• Experience with Class III devices, IDE, or PMA is a plus.
• Familiarity with Agile is a plus.
• Strong communication and problem-solving skills.
• Ability to work independently and collaborate with cross-functional teams.

Responsibilities

• Support mechanical design and R&D activities for medical devices.
• Support product sustaining and lifecycle projects.
• Perform hands-on device testing and troubleshooting.
• Develop prototypes and engineering fixtures.
• Support lab equipment maintenance and calibration.
• Create and execute test protocols and reports.
• Develop bench-top testing methods.
• Analyze test data and engineering results.
• Support design verification and validation activities.
• Maintain Design History File documentation.
• Support design control and change control activities.
• Work with Quality, Manufacturing, Regulatory, and R&D teams.
• Support product development from concept to commercialization.
• Identify project risks and support resolution.
• Ensure engineering activities follow FDA, GMP, and QMS requirements.

Skills

Strong communication

Problem solving

Independent work

Cross-functional collaboration

Statistical methods (DOE/ANOVA)

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Fixture design

Prototype development

Job description

Stark Pharma Solutions Inc. is seeking a Mechanical Engineer to support medical device product development, testing, troubleshooting and mechanical design in a regulated environment.

Focus areas include disposable devices, prototype development, design controls and cross-functional collaboration. The role requires 7+ years in medical devices, SolidWorks prowess, fixture design, and comprehensive knowledge of FDA/GMP/QMS requirements.