Senior Design Quality Assurance Engineer - Medical Device #8944

Enhanced Compliance Inc.; Marlborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Enhanced Compliance Inc. in Marlborough, MA, is seeking a design controls specialist with a strong background in medical devices to lead DHF remediation and support regulatory compliance activities.

You will review design documentation, develop remediation strategies, and collaborate with cross-functional teams to reconstruct development history and provide evidence for design decisions. Strong technical writing and regulatory knowledge are essential.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
• 3-5 years of experience in the medical device industry or another regulated environment.
• Working knowledge of Design Controls, Risk Management, and Product Development processes.

Responsibilities

• Participate in Design History File (DHF) remediation activities to ensure compliance with applicable design control requirements, regulatory expectations, and company procedures.
• Review and assess existing design documentation to identify gaps, inconsistencies, and opportunities for improvement.
• Develop and execute remediation strategies for design inputs, design outputs, design verification, design validation, design reviews, risk management, and traceability documentation.
• Partner with cross-functional teams to reconstruct product development history and establish objective evidence supporting design decisions.
• Author, revise, and review quality records and remediation deliverables to support audit readiness.
• Support the development and maintenance of requirements traceability matrices and design control documentation packages.

Skills

Technical writing

Regulatory compliance

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in Biomedical/Mechanical/Electrical/Quality Engineering or related technical discipline

Job description

• Location Marlborough, MA,Marlborough, MA, 01752,United States
• Employee Type Contractor or FT Employee
• Required Degree 4 Year Degree

Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

What You'll Do

• Participate in Design History File (DHF) remediation activities to ensure compliance with applicable design control requirements, regulatory expectations, and company procedures.
• Review and assess existing design documentation to identify gaps, inconsistencies, and opportunities for improvement.
• Develop and execute remediation strategies for design inputs, design outputs, design verification, design validation, design reviews, risk management, and traceability documentation.
• Partner with cross-functional teams to reconstruct product development history and establish objective evidence supporting design decisions.
• Author, revise, and review quality records and remediation deliverables to support audit readiness.
• Support the development and maintenance of requirements traceability matrices and design control documentation packages.
• Participate in risk management activities, including hazard analyses, design FMEAs, and risk/benefit assessments.
• Apply structured problem-solving methodologies to resolve complex documentation, compliance, and process challenges.
• Collaborate with global stakeholders to drive alignment and execution of remediation plans.
• Interpret and apply FDA, ISO 13485, ISO 14971, and internal quality system requirements within remediation activities.
• Support internal audits, inspections, and remediation effectiveness reviews as required.
• Identify opportunities to improve remediation processes, tools, and methodologies, increasing efficiency while maintaining compliance.
• Serve as a design controls resource and related quality remediation initiatives.

What you will bring

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
• 3-5 years of experience in the medical device industry or another regulated environment.
• Working knowledge of Design Controls, Risk Management, and Product Development processes.
• Familiarity with FDA Quality System Regulation, ISO 13485, ISO 14971, and applicable medical device regulatory requirements.
• Strong technical writing and documentation skills.
• Demonstrated ability to independently manage multiple priorities and deliver high-quality results with minimal supervision.
• Strong analytical, organizational, and problem-solving skills.
• Effective communication skills and the ability to work across functions and global teams.

Preferred Qualifications

• Direct experience with DHF remediation, design assurance, quality engineering, or CAPA-related activities.
• Experience supporting remediation programs, compliance initiatives, or regulatory commitments.
• Knowledge of traceability methodologies and requirements management.
• Experience reviewing and creating risk management documentation, including DFMEAs and hazard analyses.
• Experience within Endoscopy or Class II/III medical device product development environments.
• Working knowledge of design control requirements under 21 CFR Part 820 and ISO 13485.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3 rd party vendor.