Design Quality Engineer: DHF & Design Controls

Redbock - an NES Fircroft company; Marlborough (MA); Hybrid; USD 85,000 - 115,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a Design Quality Engineer to support DHF remediation and design controls in a regulated medical device setting. You will partner with Quality, R&D, Regulatory Affairs, and cross-functional teams to assess, remediate, and strengthen documentation across portfolios.

The ideal candidate is a self‑driven quality professional with strong technical writing, judgment, and hands‑on approach to closing documentation gaps while ensuring regulatory

Qualifications

• Bachelor-level degree in a relevant engineering or quality discipline.
• 3–5 years in medical device or regulated environments.
• Experience with design controls, risk management, and product development processes.
• Hands‑on risk management documentation such as DFMEAs and hazard analyses.
• Familiarity with FDA QSR, ISO 13485, ISO 14971, and medical device regulations.
• Strong technical writing and ability to work with cross‑functional teams.

Responsibilities

• Review DHFs to identify gaps, inconsistencies, and compliance risks.
• Develop remediation strategies for design controls documentation.
• Author and revise design control records and quality documents for audit readiness.
• Reconstruct product development history with cross-functional teams.
• Maintain requirements traceability matrices and design control packages.
• Support risk management activities including DFMEAs and hazard analyses.
• Interpret FDA/ISO requirements and align remediation activities accordingly.
• Collaborate with global stakeholders to close deliverables and resolve issues.
• Assist internal audits, inspections, and remediation effectiveness reviews.
• Identify opportunities to improve remediation processes and tools.

Skills

Quality engineering

Design controls

Risk management

Technical writing

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or related

Job description

Redbock - an NES Fircroft company is seeking a Design Quality Engineer to support DHF remediation and design controls in a regulated medical device setting. You will partner with Quality, R&D, Regulatory Affairs, and cross-functional teams to assess, remediate, and strengthen documentation across portfolios.

The ideal candidate is a self‑driven quality professional with strong technical writing, judgment, and hands‑on approach to closing documentation gaps while ensuring regulatory