Development Quality Engineer II

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Abhinav Chakraborty at email address     can be reached on #

630-576-1925

.
 
We have Contract role Quality Engineer for our client at Plymouth, MN. Please let me know if you or any of your friends would be interested in this position.
 
Position Details:
Quality Engineer - Plymouth, MN
Location                             : Plymouth, MN - 55442
Project Duration            : 12+months contract with potential to extend
 
Basic Qualifications:

• Bachelor’s degree in Engineering or Technical Field.
• Experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
• Experience in medical devices and associated regulations/standards.
• Experience in test method development and validation
• Experience in preparing risk assessments, FMEA and other risk documents.

 
Preferred Qualifications:

• Advanced Degree in Engineering/Technical Field
• Experience in active implantable medical devices.
• Knowledge of requirements management tools (e.g., JAMA) and use of problem reporting systems (e.g., JIRA).
• Working knowledge of statistics and its application to verification and validation

 
Duties:

• Lead and support Risk Management activities, specifically on devices with Electrical Design and Software Capabilities.
• Risk Management activities will be from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, Design FMEAs, and, Software FMEAs.
• Participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables
• Lead identification of essential outputs and generate Essential Output reports
• Lead efforts in support of software verification compliance to standards such as 62304
• Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects,
• Accountable for generation of PDP design verification test plans/reports for product/system requirements
• Work with design engineering in the completion of customer/system/product requirements
• Work with design engineering in the completion of product verification and validation
• Support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements
• Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements, additional duties may be identified by functional management based on the current project/business objectives.

 
Education:

• Bachelor level degree in an Engineering Discipline or Technical Field with medical device experience

 
Required skills:

• ABO
• Development Quality
• Electrical Heavy
• Engineering Degree
• Medical Experience
• Risk Management
• Working on Teams

 
Top 3 Skillset

• Risk Management
• Led or Worked on Deliverables
• Design verification activities

 
 
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Abhinav Chakraborty at email address     can be reached on #

630-576-1925

.
 
 
About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.