United Pharma · 6 hours ago
Design Quality Engineer
New York, NY
Contract
Onsite
Senior Level, Lead/Staff
8+ years expUnited Pharma is seeking an experienced Design Quality Engineer to lead and support risk management activities across new product development and continuous improvement initiatives. This role is critical in ensuring compliance with global medical device regulations and involves collaboration with cross-functional teams throughout the product lifecycle.
Staffing & Recruiting
Hiring Manager
Chandra Sekhar.s
Responsibilities
Lead and provide expert guidance on Risk Management and Human Factors Engineering activities throughout all phases of product development and lifecycle management
Plan, organize, execute, and report risk management activities in collaboration with cross-functional project teams
Develop, implement, and continuously improve risk management processes, procedures, tools, and technologies
Establish and manage key performance indicators (KPIs) and metrics to evaluate the effectiveness of risk management practices
Conduct SWAT assessments to identify gaps and drive continuous improvement across risk management and related business processes
Support and lead New Product Development (NPD) , Sustaining Engineering , and Continuous Improvement projects of varying complexity
Partner with internal stakeholders and external design/development vendors to ensure timely delivery of Design and Reliability Assurance deliverables
Provide technical support related to planning, execution, documentation, reporting, and communication of design assurance activities
Work independently while managing priorities and resources to meet organizational goals and project timelines
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or Systems) or Science (Biology or Chemistry)
Minimum 8 years of experience in a Quality Assurance or Design Quality role within the medical device or other regulated industry
Strong working knowledge of: ISO 14971 (2019) – Risk Management
ISO 13485 – Quality Management Systems
IEC 62366 – Usability Engineering
FDA QSR and cGMP
Medical Device Directive (MDD)
Experience with Design for Six Sigma (DFSS) methodologies
Solid background in design and manufacturing processes
Demonstrated expertise in risk management tools, processes, and best practices
Strong analytical and problem-solving skills with proficiency in statistical sampling and data analysis methods
Excellent written, verbal, and organizational communication skills
Proficient in MS Office Suite and statistical software tools
Ability to work independently with minimal supervision and manage multiple priorities effectively
Preferred
Familiarity with EU MDR requirements
Conversational Spanish language skills
Experience supporting global, cross-functional development teams
Company
United Pharma
United Pharma Solutions is a professional company dedicated to business development in the pharmaceutical industry.
11-50 employees
H1B Sponsorship
United Pharma 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Early StageCompany data provided by crunchbase