QvalFocus Inc. · 1 month ago
Systems Engineer – Medical Device Design Controls
United States
Contract
Remote
Senior Level
5+ years expQvalFocus Inc. is seeking an experienced Systems Engineer with a strong background in medical device product development. The role involves leading Design Controls activities and ensuring compliance with FDA regulations, while collaborating with cross-functional teams throughout the product development lifecycle.
Human ResourcesCareer PlanningRecruitingStaffing Agency
Hiring Manager
Nisha Vaidya
Responsibilities
Lead and support Design Controls activities for new and existing medical device products in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory standards
Establish and maintain end-to-end traceability between user needs, design inputs, risk controls, verification activities, and design validation requirements
Collaborate with cross-functional teams to ensure user needs are appropriately translated into product requirements and validated through documented evidence
Support the development, review, and maintenance of Design History Files (DHF), trace matrices, and validation documentation
Partner with hardware, software, systems, quality, and regulatory teams to ensure proper integration of design controls throughout the product lifecycle
Support and coordinate Design Verification and Validation (V&V) activities to ensure products meet functional, performance, and regulatory requirements
Prepare, review, and maintain technical documentation, engineering records, protocols, reports, and design control deliverables
Provide project updates related to scope, timelines, risks, and compliance status to leadership and stakeholders
Identify opportunities for process improvements related to design controls, traceability, and systems engineering practices
Support remediation, compliance, and quality improvement initiatives as needed
Qualification
Required
5–8 years of Systems Engineering experience within the medical device industry or other highly regulated environments
Strong experience with Design Controls, traceability management, and Design Verification & Validation (V&V)
Experience establishing traceability from user needs through design validation and product release
Strong understanding of FDA 21 CFR Part 820, ISO 13485, and medical device regulatory requirements
Experience working within cross-functional engineering and quality teams
Excellent written and verbal communication skills in English
Strong analytical, organizational, and problem-solving abilities
Detail-oriented with the ability to manage multiple priorities in a fast-paced environment
Preferred
Experience with risk management processes and ISO 14971
Familiarity with risk analysis, risk assessment, and mitigation activities
Experience with requirements management and traceability tools
Knowledge of V&V methodologies, protocols, and regulatory documentation practices
Prior experience supporting remediation or compliance-driven projects is a plus
Strong technical documentation and reporting skills
Ability to work independently and collaboratively across teams
Proactive mindset with strong ownership and accountability
Ability to prioritize and manage multiple projects simultaneously
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
51-200 employees
H1B Sponsorship
QvalFocus Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
98%
Represents job field similar to this job
Engineering and Development
Management and Executive
Trends of Total Sponsorships
*2026 (10)
2025 (33)
2024 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase