Design Assurance/Design Quality Engineer

**Job 2994 - Design Assurance/Design Quality Engineer - Contract located in Middlesex County, Massachusetts

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.** **Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

Hybrid - Onsite 3 days per week.** About The Role This role offers an opportunity to drive critical Design History File (DHF) remediation and Design Controls initiatives supporting our client's commitment to patient safety, product quality, and regulatory compliance. As a member of the team, this individual will partner closely with Quality, R&D, Regulatory Affairs, and cross-functional stakeholders to assess, remediate, and strengthen design control documentation across legacy and active product portfolios.

The ideal candidate is a motivated self-starter who thrives in a fast-paced environment, is comfortable navigating ambiguity, and demonstrates strong critical thinking and problem-solving skills. This individual must be capable of independently identifying gaps, developing compliant solutions, and driving work to completion while maintaining a high level of quality and attention to detail.

Key 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.
• 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 for Project Guardian and related quality remediation initiatives.

What We're Looking For Minimum 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.
• 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.

Candidate Profile We are seeking a highly motivated, self-driven professional who enjoys solving complex problems and working independently. The successful candidate is comfortable navigating incomplete information, proactively identifies issues and solution paths, and demonstrates persistence in driving remediation activities to closure. They combine strong technical judgment with the ability to collaborate effectively across a diverse set of stakeholders and functions.

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position

**Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.**