Senior Requirements Engineer - MedTech Tools & Compliance

Stark Pharma; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma in Pleasanton, CA is seeking a qualified candidate to plan and execute the migration of requirements from legacy tools into new platforms. The role demands a Bachelor's degree in a relevant field and at least 5 years of experience with enterprise requirements management tools in regulated environments. Responsibilities include administering tools, maintaining documentation, and providing training to engineers. This is a 1-year contract position, contributing directly to the medical device development process and ensuring compliance with industry standards.

Qualifications

• Minimum 5 years of experience administering or configuring enterprise requirements management tools.
• Ability to quickly learn and adopt new tools.
• Experience supporting regulated development environments.

Responsibilities

• Plan and execute migration of requirements and related data from legacy tools.
• Administer, configure, and maintain enterprise requirements management tools.
• Develop and maintain a requirements management plan.
• Create and maintain standardized requirements templates.
• Provide training and ongoing support to engineers.

Skills

Requirements migration from legacy tools

Understanding of medical device product development

Excellent verbal and written communication skills

Collaborative work environment skills

Education

Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related discipline

Tools

DOORS

Jama

Codebeamer

Job description

Stark Pharma in Pleasanton, CA is seeking a qualified candidate to plan and execute the migration of requirements from legacy tools into new platforms. The role demands a Bachelor's degree in a relevant field and at least 5 years of experience with enterprise requirements management tools in regulated environments. Responsibilities include administering tools, maintaining documentation, and providing training to engineers. This is a 1-year contract position, contributing directly to the medical device development process and ensuring compliance with industry standards.