Engineer, Design Assurance in Minneapolis, MN at Volt

Date Posted: 9/14/2018

Job Snapshot

Job Description

Design Assurance Engineer (12-month contract) $25-28/hr.

Plymouth, MN

Job Summary:

A Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system.  Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Responsibilities:

  • Lead on-time completion of Design Control Deliverables
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Perform other duties and responsibilities as assigned by management.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Equipment:

May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.

Working Conditions:

Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

Physical Demands:

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking.  Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.  Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

Qualifications:  

Minimum Qualifications

  • Bachelor level degree in Engineering or Technical Field
  • 5+ years’ experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Solid communication and interpersonal skills
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Advanced computer skills, including report writing skills
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to maintain regular and predictable attendance
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multitasks, prioritizes and meets deadlines in timely manner

Preferred Experience

  • Prior medical device experience
  • Experience working in a broader enterprise/cross-division business unit model
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Product Lifecycle Management (PLM) systems (e.g., Windchill)

Volt is an Equal Opportunity Employer