Design Assurance Engineer II at Imricor Medical Systems Inc

Burnsville, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Jul, 26

Salary

110000.0

Posted On

25 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Assurance, Quality Systems, Product Development, Risk Management, Design Controls, Test Method Validation, Statistical Analysis, Root Cause Analysis, Regulatory Compliance, DHF Development, CAPA, Nonconformance Management, Data Analysis, Technical Writing, Communication Skills

Industry

Medical Equipment Manufacturing

Description

Description Supervisor’s Title: Director of Quality Exempt or Non-Exempt: Exempt Location: Must be able to work at the Burnsville location. Compensation: The expected annual base salary range for this Minnesota-based position is $80,000-$110,000. 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 The Design Assurance Engineer II 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 outlined in the environmental, health, and safety policies. Essential Functions: Executes and supports completion of product development deliverables Creates and supports the 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 specification. 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, Science, or technical field 2+ years’ experience in Engineering and/or Quality. Additional education may be substituted for years of experience. Must be able to work independently under limited supervision. 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 Advanced computer skills, including statistical/data analysis and protocol/report writing. 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. 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. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Responsibilities

The Design Assurance Engineer II supports product development by ensuring compliance with regulatory standards and quality management systems. They are responsible for managing product risk, authoring verification and validation plans, and leading characterization testing.