Development Quality Engineer II

Position Title: Development Quality Engineer II

Work Location: Plymouth, MN 55442

Assignment Duration: 12 Months

Position Summary: 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.

Key Responsibilities:

• 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. Qualification & Experience:

• Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills
• Development Quality
• Electrical Heavy
• Medical Experience
• Risk Management
• Working on Teams Risk Management
• Led or Worked on Deliverables
• Design verification activities

• 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.

• 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