Design Assurance Engineers and/or Systems Engineers (Hardware/Software)

Job 2646 - Design Assurance Engineer - Contract located near Minneapolis, Minnesota

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

Position Overview

We are seeking experienced Design Assurance Engineers and/or Systems Engineers (Hardware/Software) to support a comprehensive Design History File (DHF) gap assessment and remediation initiative.

Contractors in this role will evaluate design completeness, traceability, and risk alignment for existing medical devices, ensuring compliance with internal procedures and global regulatory requirements.

This work requires deep expertise in design controls, risk documentation, verification/validation, and post-market feedback integration.

Onsite

Duration – 6 months with potential to extend

Key Responsibilities

• DHF Gap Assessment
• Review design documentation (user needs, system requirements, design inputs/outputs, verification, validation) for traceability, completeness, and alignment.
• Confirm that requirements properly connect to:
• Hazard analyses
• Risk management files (e.g., DFMEA, FTA, HHEs)
• Risk controls and mitigations
• Evaluate verification and validation test methods to ensure they are appropriate, justified, and validated.
• Post-Market & Field Signal Evaluation
• Assess whether existing design requirements and risk mitigations sufficiently address:
• Complaint trends
• Field actions
• CAPA inputs
• Known product signals
• Identify gaps where post-market learnings should be incorporated into the design or risk documentation.
• Gap Remediation & Execution Support
• Prioritize identified gaps and support remediation activities.
• Update or create new DHF documentation within internal systems.
• Participate in or lead cross-functional reviews to ensure closure of identified gaps.
  

Additional Scope & Expectations

Quality & Compliance Support

• Provide engineering support aligned to:
• Design controls (inputs, outputs, V&V, design reviews)
• Risk management processes
• Post-market quality activities
• Ensure deliverables comply with internal SOPs and global regulations (e.g., FDA, ISO 13485, ISO 14971).
  

DHF & Documentation Management

• Create, remediate, and finalize DHF documentation.
• Ensure all documentation is complete, accurate, audit-ready, and traceable across the design lifecycle.
  
  

Project Execution & Cross-Functional Coordination

• Develop project timelines and manage assigned deliverables.
• Work closely with systems engineering, R&D, quality, and regulatory functions.
• Communicate progress, risks, and needs to stakeholders.
  
  

Process Improvement

• Use quality tools and metrics to identify and execute process improvements across sustaining engineering or documentation workflows.
  
  

General Expectations

• Provide routine status updates and progress reports.
• Participate in meetings, reviews, and project checkpoints.
• Flex to support additional engineering or documentation activities required to meet project objectives.
  
  

Required Skills & Experience

• 5 years of experience in Systems Engineering, Quality Engineering, or Design Assurance in a regulated industry (medical devices strongly preferred).???????
• Strong understanding of:
• Design controls (21 CFR 820.30 / ISO 13485)
• Risk management (ISO 14971)
• Verification & validation methodologies
• Complex electro-mechanical or software-based systems
• Experience assessing or remediating DHFs, technical files, or risk files.
• Ability to analyze complex design architectures and trace requirements.
• Familiarity with post-market quality systems (complaints, CAPA, field actions).
• Strong documentation and technical writing skills.
  

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.