Mechanical Engineer

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

Mechanical Engineer

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India.

We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Mechanical Engineer

Location: Fremont, CA
Duration: Long Term

Job Overview

We are seeking a Mechanical Engineer to support medical device product development, testing, troubleshooting, and mechanical design activities in a regulated environment.
The role will focus on disposable medical devices, prototype development, design controls, testing, and cross-functional engineering support.

Key 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.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or related engineering field.
• 7+ years of experience in the medical device industry.
• Strong experience with SolidWorks and mechanical design.
• Experience with fixture design and prototype development.
• Hands‑on experience with 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.