Software Design Control Engineer

Cynet Systems Inc; Sunnyvale (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

Join a forward-thinking staffing and recruiting firm as a Software Design Control Engineer, where you'll play a crucial role in delivering technical documentation and supporting innovative projects. Collaborate closely with cross-functional teams to develop and maintain design control infrastructure, ensuring operational effectiveness and compliance with regulatory standards. This position offers an exciting opportunity to work in a dynamic environment, contributing to the development of cutting-edge medical devices. If you're passionate about engineering and eager to make a difference, this role is perfect for you.

Qualifications

• 5+ years of experience, preferably in medical devices.
• Familiarity with design controls and regulatory standards.

Responsibilities

• Deliver technical documentation with minimal resource impact.
• Collaborate with cross-functional teams to support design control.

Skills

Technical Documentation

Design Control

Risk Management

Trace Reports

Excellent Communication Skills

Problem-Solving

Education

BS degree in Engineering

Tools

MKS

Polarion

Job description

• As a Software Design Control Engineer, candidate will be responsible for delivering technical documentation to support projects with minimal impact on resources while ensuring operational effectiveness.
• Candidate will work within the Multiport software team and collaborate closely with Design and Product Engineering, Quality, and Document Control teams.
• Develop, execute, maintain, and support design control infrastructure (risks/FMEAs, requirements, etc.).
• Generate trace reports, identify, and resolve gaps through collaboration with various departments.
• Inform design decisions based on documented product risk and design control strategy.
• Support the Multiport team in creating trace, requirement, test protocol/report, TLTR, Known Anomaly List documents for regulatory submissions and software releases.

Job Description:

Pay Range: $50/hr - $68/hr

Responsibilities:

• Deliver technical documentation supporting projects with minimal resource impact while ensuring operational effectiveness.
• Collaborate with the Multiport software team and cross-functional departments.
• Develop, maintain, and support design control infrastructure (risks, FMEAs, requirements).
• Generate trace reports, identify gaps, and collaborate to resolve them.
• Make informed design decisions based on product risk documentation and control strategies.
• Create necessary documents for regulatory submissions and software releases, including trace, requirements, test protocols/reports, TLTR, and Known Anomaly List.

Experience/Skills:

• BS degree in engineering or equivalent.
• 5+ years of industry experience, preferably in medical devices.
• Familiarity with design controls, risks, trace reports.
• Strong writing and grammar skills for content development.
• Ability to quickly understand and communicate complex technical concepts.
• Excellent communication skills for diverse audiences.

Preferred Qualifications and Skills:

• Experience creating or modifying risks, trace reports, and requirements.
• Knowledge of US and international medical device regulations (FDA, MDR, China PTR, etc.).
• Experience with design control software (e.g., MKS, Polarion).
• Strong organizational skills, ability to manage deadlines, priorities, and time.
• Team player capable of working with SMEs and stakeholders across disciplines.
• Quick learner, process-oriented, adaptable to change.
• Problem-solving skills with attention to detail and integrity.
• Background in system engineering principles like requirements, verification, and validation.

About the company

Cynet Systems Inc. is a diverse staffing and recruiting firm composed of technical visionaries dedicated to helping organizations achieve their technological goals through top talent. We welcome passionate professionals to join our team and contribute to innovative projects.