Design Quality Engineer in Palm Beach Gardens
Role details
Job location
Tech stack
Job description
The Design Quality Engineer will act as the quality representative and design control lead on cross-functional new product development (NPD) and sustaining engineering teams. This role ensures that orthopedic implants and associated instrumentation are developed and manufactured in compliance with internal QMS, FDA 21 CFR 820, ISO 13485, and ISO 14971 standards. The ideal candidate will facilitate risk management activities, verify design outputs, and ensure a smooth design transfer to manufacturing, * Design Control Leadership: Lead and support Design Control activities (planning, design inputs, outputs, verification, validation, and design transfer) across the product lifecycle.
- Risk Management: Facilitate and lead risk management activities, including development of Risk Management Plans, Hazard Analysis, and Design Failure Mode Effects Analysis (DFMEA) for orthopedic products.
- Verification & Validation (V&V): Approve design verification/validation plans, protocols, and reports to ensure compliance with product requirements, including mechanical testing, tolerance analysis, and anatomical lab testing.
- Design Transfer: Ensure the successful transfer of new products to production by assisting in process validation requirements (IQ/OQ/PQ) and reviewing manufacturing documentation.
- Technical Documentation & Audits: Review and approve Design History Files (DHF) and Device Master Records (DMR) for conformance. Support internal and 3rd party audits (FDA/Notified Body).
- Post-Market Surveillance (PMS): Utilize post-market data and analytics to report on product performance in the field, providing feedback to R&D for continuous improvement.
- Root Cause Analysis: Lead quality-related problem-solving and root cause investigations for design-related issues, complaints, and CAPAs.
- Regulations: Strong understanding of FDA 21 CFR 820, ISO 13485, and ISO 14971.
Requirements
HCLTech is looking for a highly talented and self- motivated Design Quality Engineer to join it in advancing the technological world through innovation and creativity., * Technical Skills: Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and machining methodologies (titanium and stainless steel).
- Tools: Proficient in statistical software tools (e.g., Minitab) for data analysis and risk analysis., * Certified Quality Engineer (CQE), Certified Six Sigma Green/Black Belt.
- Experience with EU MDR regulatory submissions.
- Experience with surgical instrumentation and/or implantable devices.
Core Competencies
- Strong analytical, problem-solving, and critical thinking skills.
- Effective communication and interpersonal skills to work within multi-disciplinary, cross-functional teams.
- Detail-oriented with a focus on compliance and accuracy.
Benefits & conditions
Pay Range Minimum: $38.46 per hour
Pay Range Maximum: $47.00 per hour
HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of , , , , , , , , physical or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcltech.com for investigation.
Compensation and Benefits
A candidate's pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.
How You'll Grow
At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.
