Design Assurance EngineerMedical Engineering Consultants (MEC) • Carlsbad, California, United States
Design Assurance Engineer
Medical Engineering Consultants (MEC)
- Carlsbad, California, United States
- Carlsbad, California, United States
À propos
Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement 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 SMEs (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.
Job Purpose As a Design Assurance Engineer you will support new product development and commercialized products that improve the delivery of care for patients around the world. In this highly visible role you will influence design strategy, risk management and lifecycle quality activities while partnering with cross‑functional leaders in R&D, manufacturing, regulatory and clinical. You will thrive in a high‑performance culture that values diversity, innovation, global collaboration and a winning spirit – where continuous learning and meaningful impact are part of every project.
Your Responsibilities Will Include
Apply advanced systematic problem‑solving methodologies to resolve complex product and process quality issues across the product lifecycle.
Provide quality engineering insights on cross‑functional new product development teams ensuring robust design inputs, verification and validation strategies and regulatory compliance.
Drive the implementation and continuous improvement of risk management activities including hazard analysis, fault tree analysis and FMEAs ensuring alignment with ISO 14971 and internal standards.
Develop and approve verification and validation protocols and reports applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
Establish, review and maintain Design History File (DHF) documentation including design requirements, specifications and design outputs ensuring inspection readiness.
Execute design change control activities assessing product and process impacts while ensuring compliance and patient safety.
Monitor field performance of new and established medical devices, analyze trends against risk assessments and drive corrective and preventive actions as needed.
Mentor junior engineers and contribute to the development of best practices that elevate team capability and performance.
Required Qualifications
Bachelor of Science degree in Engineering or a related technical field.
Minimum of 3 years' experience in quality engineering or design assurance within the medical device industry.
Demonstrated expertise in risk management, design controls and product verification and validation.
Strong knowledge of global quality system regulations and standards including ISO 13485 and ISO 14971.
Proven ability to lead cross‑functional initiatives and influence stakeholders at multiple organizational levels.
Strong written and verbal communication skills.
Ability to manage multiple priorities and navigate ambiguity in a fast‑paced environment.
Preferred Qualifications
Degree in biomedical or mechanical engineering.
Experience supporting structural heart, cardiovascular or implantable medical devices.
Certification in quality engineering e.g. CQE or related credential.
Demonstrated use of advanced quality tools and statistical methodologies.
Passion for continuous improvement, talent development and building high‑performing teams.
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.
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Compétences linguistiques
- English
Avis aux utilisateurs
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