Senior Design Assurance Engineer at Imricor Medical Systems Inc

Burnsville, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Dec, 25

Salary

130000.0

Posted On

24 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Assurance, Quality Systems, Documentation Practices, Corrective Actions, Preventive Actions, Design Controls, Test Method Validation, Regulatory Compliance, Statistical Techniques, Risk Management, Communication Skills, Team Collaboration, Product Development, Medical Device Regulations, ISO Standards, Root Cause Analysis

Industry

Medical Equipment Manufacturing

Description

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

Responsibilities

The Senior Design Assurance Engineer supports product development to ensure a successful production launch and delivery of high-quality products. This role involves collaborating with various teams and complying with quality management system requirements.