Senior Design Assurance Engineer

Description

Supervisor’s Title: Director of Quality

Exempt or Non-Exempt: Exempt

Location: Must be able to work at Burnsville Location

Compensation: The expected salary for this Minnesota-based position is between $105,000-130,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function

This design assurance engineer position supports product development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality initiatives. This position interacts closely with the Engineering team as well as Operations, Quality Systems, Quality Assurance, Marketing, and Regulatory. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Essential Functions

• Executes and supports completion of product development deliverables
• Creates and supports development of DHF to ensure content is complete, accurate, and compliant with regulatory standards
• Supports the development and maintenance of customer requirements, product requirements, and product specifications
• Collaborates cross-functionally to lead and support completion and maintenance of product risk management deliverables
• Authors design verification and design validation plan and report documents
• Implements appropriate sampling inspection and supports qualification activities for purchased components
• Supports design test method development, and leads method validation activities
• Utilizes statistical techniques to lead and support characterization, verification, and validation testing and root cause analysis
• Supports quality system related deliverables including nonconformances and CAPAs
• Performs other related duties and responsibilities, as assigned.
  
  

Requirements

Qualifications:

• Bachelor of Science in engineering
• 5 years’ experience in Engineering or Quality in the medical device industry.
• Must be able to work independently under limited supervision.
• Advanced knowledge of basic Quality Systems and good documentation practices.
• Experience in investigating and implementing Corrective and Preventive Actions
• Experience in design controls and test method validation
• Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
• Strong communication skills, both verbal and written.
• Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
  
  

Working Conditions

Light work, exerting up to 20 lbs. of force or less.

Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.

Requires typing, talking and hearing.

Travel

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.