Superior Jobs

 

E4 - Design Quality Engineer

Apply
  • ID: 474623
  • Posted: 11/19/2020
  • Location: Lakewood, CO
  • Category: Pro - Engineering
  • Job Type: Direct Placement
  • Duration: Direct Placement

Description

Acara Solutions is assisting our client in Denver Colorado to fill a critical role within their Design Quality Team. This is a Direct Hire role with excellent compensation and benefits. Candidates must be a US Person or Green Card Holder to be considered. 

The Design Quality Engineer (QE) supports release of world class quality products by ensuring rigorous execution of the design and development activities and compliance to the QMS procedures.  Ownership includes critical deliverables of the development process including Risk Management evidence, Test Method Validation activities, Statistical Analysis/Method support, and Design Verification planning/execution. They ensure adherence to customer and regulatory requirements are demonstrated and help to ensure successful transfer of the design to manufacturing.

ESSENTIAL DUTIES
  • Works in a cross-functional, collaborative, team-based environment; collaborating closely with I&D project leads and teams to bring products to market
  • Ensures compliance to design and development QMS procedures, 
  • Facilitates and supports risk management activities including Hazard Analysis and FMEA
  • Stats
  • Responsible for Test Method Validation activities to support Design Verification Executional
  • Assists and may lead Design Verification planning and protocol development
  • Contributes to the development and refinement of Design Control policies and procedures to ensure they comply with appropriate standards, regulations, and industry best practice
  • Anticipates roadblocks, provide direction for navigating the quality system and supporting applications.
  • Takes an active role in Design Reviews to assess quality of the design, design for reliability, manufacturing, and servicing. 
  • Responsible for accurate, independent evaluation of Design History File documentation and overall compliance to the Quality System.  
  • Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
  • Directs one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects. 
  • Develops new processes that have a significant impact on multiple disciplines. 
  • Contributes to the establishment of business objectives, goals, budgets and costs as requested.
  • Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively.
  • Mentors less experienced engineers.
  • Provides broad-based direction for subordinates and colleagues within functional area and cross functionally. 
  • Applies technical expertise to complex tasks with in-depth knowledge of related work areas.   
  • Employs in-depth knowledge of cross functional and related technical areas, applying knowledge to other areas.
  • Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues engineering staff and management.  
  • Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Keeps updated on recent technical advances within the industry and applies this knowledge to products and processes.
 
 
OTHER DUTIES AND RESPONSIBILITIES
  • Work direction responsibility may include technicians and junior engineers. 
  • May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
  • May contribute to the establishment of business objectives, goals, budgets and costs. 
 
 
Job Requirements

 
MINIMUM QUALIFICATION REQUIREMENTS
 
Education
  • Bachelor’s of Science degree or Master of Science degree in Engineering preferred. 
  • Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
 
Experience
  • Minimum 8 years experience.
  • Two years of GMP manufacturing experience required. 
 
Skills
  • Requires demonstrated skills in Test Method Validation, Design Verification, Statistical Analysis and Risk Assessment activities
  • Demonstrated interactive skills in, cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
  • Represents the organization as the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
  • Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
  • Knowledge and ability to implement FDA or regulatory requirements as necessary.  
  • Driver for acquiring resources and building consensus across products.
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
  • Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
  • Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to medical device development (e.g. ISO 13485, FDA GMP, 21 CFR 820, ISO 14971, EU MDR)
  • Experience with Software as a Medical Device and knowledge of 62304 and Agile development methodologies preferred
  • Six-Sigma and/or Lean Training preferred
  • Demonstrated ability to communicate effectively both verbally and in writing.  
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
 
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.



Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron?s strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
Apply
 

Already have an account? Log in here