Design Quality Assurance - acquisitions

Job 2746 - Design Quality Assurance - Contract located in Miami, Florida

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.

Remote

Overview

The Design Quality Engineer position will work on Integration projects, specifically supporting product Design Control integration under the direction of the Design Control Workstream lead.

This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with our Client's and regulatory requirements.

This Design Quality role supports the active implantable design process for both existing and new products in Urology Division

Your Responsibilities Will Include

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues
• Acts as an effective team member in supporting quality disciplines, decisions and practices
• Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records and processes
• Write various technical documentation for procedure execution, technical rationale and evidence of the development process
• Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration and other DA related integration and hybridization processes
• Support Post Market activities, as necessary, of risk based on post-market signals
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory-requirements and internal standards
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications and Prints)
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs, Task Analysis)
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
• Partner cross-functionally to identify and support value improvement efforts to support business goals
  
  

Required Qualifications

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
• 9 years of experience in design assurance, new product development or related medical device / regulated industry experience
• Self-motivated with a passion for solving problems and a bias for action
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• Ability to effectively work and collaborate in a mixed onsite remote environment
• Demonstrated experience creating detailed technical documents
  
  

Preferred Qualifications

• Experience working with medical electrical equipment and/or active implantables
• Quality Integration experience
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experienced problem solver, capable of facilitating the problem-solving process
• Adaptable and effective collaborator in a team environment or in self-directed work
• Experience with design changes, complaint reduction, and corrective action
  
  

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.