Design Quality Assurance Engineer

Job 2586 - Design Quality 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.

Hybrid – 3 days per week

Our client values collaboration and synergy. We have an exciting opportunity for a Design Quality Engineer supporting development projects within our clients Cardiology division. This position supports a major product category with high visibility. This person will utilize their established understanding of design controls to contribute to a cross‑functional team tasked to evaluate the health of existing product design history files and triage the need for remediation.

• In‑depth understanding and application of Design Control and Risk Management concepts.
• Provide quality and compliance input to project teams.
• Provide expertise to assess adequacy of test‑method validation coverage, documentation and execution.
• Independently and cross‑functionally assess acceptability of design requirements and risk controls as demonstrated in the design history file documentation.
• Expectations include demonstrated acumen of user needs, hazard analyses and design verification deliverables.
• Apply sound systematic problem‑solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

• Bachelor’s degree in mechanical engineering, biomedical engineering or related engineering field of study.
• Minimum of 8 years of experience in design assurance, quality or related medical device or regulated industry experience.
• Experience in new product development: driving and creating risk management deliverables, risk management plan/report, hazard analysis, task analysis, DFMEA, validating test methods, supporting the creation of design requirements, design verification and validation.
• ISO 13485, ISO 14971, CFRs and Quality System Regulations understanding and demonstrated use.
• Excellent organizational and planning skills and drive for results.
• Strong communication skills (verbal, written).
• Demonstrated use of quality tools/methodologies.

• Experience in developing test methods.
• Problem solver capable of facilitating the problem‑solving process.
• Adaptable and effective collaborator in a team environment and in self‑directed work.
• Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.
• Experience with Class III medical devices.

• Sponsorship is not available for this position.

AAP/EEO DFWP

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

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.