INGENYX- Design Quality Assurance Engineer II **Date:** Aug 9, 2026 **Location:** Mansfield, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :13833 Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives. For more information, please visit Ingenyx.com **Position Summary** The Design Quality Assurance (DQA) Engineer is responsible for ensuring that product design and development activities comply with applicable regulatory and quality requirements, including ISO 13485, EU MDR (2017/745), MDSAP, and FDA 21 CFR Part 820 (QSR). This role partners closely with R&D, Manufacturing, Regulatory Affairs, and Program Management to ensure design control compliance, effective risk management, and successful product development from concept through commercialization. **Principal Responsibilities** - Ensure compliance with Design Controls (21 CFR 820.30) and ISO 13485 design and development requirements. - Provide quality oversight for design and development activities throughout the product lifecycle. - Participate in and approve design reviews, ensuring deliverables meet regulatory and internal quality standards. - Ensure completeness and compliance of Design History Files (DHF). - Lead and support design control deliverables, including: Design and development plans, Design inputs and outputs, Design verification and validation (DV&V), Design transfer. - Ensure robust traceability matrices linking user needs, design inputs, outputs, verification, and validation. - Facilitate and review risk management activities in accordance with ISO 14971: Hazard analysis, Risk assessments and mitigations, Risk-benefit analysis. - Review and approve design verification and validation protocols and reports. - Ensure test methods are scientifically sound and compliant with regulatory expectations. - Evaluate statistical justifications for sample sizes and acceptance criteria. - Ensure alignment of validation activities with intended use and user needs. - Ensure appropriate design change control processes are followed, including re-verification/re-validation as required. - Assess impact of changes on regulatory submissions and product risk. - Ensure smooth design transfer to manufacturing with complete and compliant documentation. - Review Device Master Record (DMR) elements for accuracy and completeness. - Partner with Manufacturing and Process Engineering on validation strategies (IQ/OQ/PQ alignment with design intent). - Support internal and external audits (FDA, Notified Body, MDSAP) related to design controls. - Act as SME for design quality systems during inspections. - Analyze design-related quality metrics (e.g., complaints, CAPAs, field issues). - Support CAPA investigations related to design deficiencies. **Education / Experience Requirements** - Bachelor's degree in Engineering or related technical field (Mechanical, Biomedical, Electrical, etc.). - Minimum 2-5 years of experience in medical device quality or design assurance. - Knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR), EU MDR, MDSAP, ISO 14971. **Specialized Skills / Other Requirements** - Experience supporting Class II/III medical devices. - Direct involvement in FDA inspections, Notified Body audits, or MDSAP audits. - ASQ certifications (CQE, CQA) or equivalent preferred. - Strong analytical and critical thinking skills. - Excellent written and verbal communication. - Ability to influence cross-functional teams without direct authority. - High attention to detail with strong documentation skills. - Ability to manage multiple projects in a fast-paced environment. The pay range for this position at commencement of employment is expected to be between $87,400 - 131,100 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 4