Design Quality Engineer (CNC Experience)
Job Summary
We are seeking a Design Quality Engineer to support product development and manufacturing quality activities for medical device products. The ideal candidate will have experience in design quality engineering along with a strong understanding of CNC machining processes and manufacturing. This role requires close collaboration with Design Engineering, Manufacturing Engineering, Operations, and Regulatory teams to ensure products meet quality, regulatory, and customer requirements throughout the product lifecycle.
Candidates with prior Johnson & Johnson (J&J) or other medical device industry experience are highly preferred.
Key Responsibilities
- Provide Design Quality support for new product development, product changes, and sustaining engineering projects.
- Partner with Design Engineering to ensure quality is integrated throughout the design and development process.
- Review product designs for manufacturability, with emphasis on CNC-machined components and critical dimensions.
- Participate in design reviews, risk management activities, and design verification/validation.
- Develop and review Design History File (DHF) documentation.
- Support Design Failure Mode and Effects Analysis (DFMEA), Process FMEA (PFMEA), and risk assessments.
- Collaborate with Manufacturing Engineering to resolve quality issues related to CNC machining and production processes.
- Investigate nonconformances, complaints, and CAPAs using structured root cause analysis tools.
- Support engineering changes, validation activities, and product transfers.
- Ensure compliance with FDA Quality System Regulations, ISO 13485, and internal quality procedures.
- Travel approximately 30%, both domestically and internationally, to support suppliers, manufacturing sites, and project activities.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, or a related engineering discipline.
- 3–6 years of experience in Design Quality Engineering or Quality Engineering within a regulated manufacturing environment.
- Experience with CNC machining processes, machining tolerances, and interpretation of engineering drawings.
- Knowledge of Design Controls (21 CFR Part 820 / ISO 13485).
- Experience with risk management tools such as DFMEA and PFMEA.
- Familiarity with verification, validation, and design transfer activities.
- Strong understanding of GD&T and engineering drawings.
- Excellent analytical, problem-solving, and communication skills.
Preferred Qualifications
- Previous experience with Johnson & Johnson, DePuy Synthes, or another medical device manufacturer.
- Experience with orthopedic or surgical medical devices.
- Working knowledge of FDA regulations, ISO 13485, ISO 14971, and GMP requirements.
- Experience supporting supplier quality and manufacturing process validation.
- ASQ Certified Quality Engineer (CQE) or similar certification is a plus.
- Knowledge of statistical analysis, Minitab, or other quality tools.
Preferred Skills
- Design Controls
- Design Verification & Validation (V&V)
- DHF Documentation
- DFMEA / PFMEA
- CAPA & Root Cause Analysis
- CNC Manufacturing Processes
- GD&T
- Risk Management (ISO 14971)
- Product Development
- Cross-functional Collaboration
- Medical Device Quality Systems
- Supplier Quality & Process Validation
This position offers the opportunity to contribute to the development of high-quality medical devices while working with cross-functional global teams in a dynamic engineering environment.
Pay: $73,035.95 - $87,957.27 per year
Work Location: In person
