Design Assurance Manager

Imricor•Burnsville, MN

66d•$135,000 - $165,000•Onsite

About The Position

The Design Assurance Manager is responsible for managing the design assurance engineering team in the execution of all new product development activities from concept to production launch. This position performs a wide variety of activities to ensure development and continuous production of high-quality products consistent with applicable regulatory requirements, established standards, and customer specifications. This position is responsible for complying with the QMS requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Requirements

Bachelor of Science in a scientific discipline or equivalent education/ training
10+ years of related work experience in roles of increasing responsibility, impact, and scope or an equivalent combination of education and work experience
Comprehensive knowledge of GMP, ISO 13485, 21 CFR 820, ISO 14971
Strong communication, analytical, and problem-solving skills

Nice To Haves

3+ years' experience managing people preferred
Class III or Class II medical device experience strongly preferred

Responsibilities

Provides Design Assurance (Design Quality) engineering leadership to directly support medical device development and design changes (Capital Equipment, Software, and Disposables).
Owns and drives deliverables related to Design Controls, Risk Management, Statistical Analysis, and Compliance for product development and commercial design changes.
Partners with management across departments to lead quality initiatives to develop and maintain a high performing, scalable, and compliant quality system.
Interprets government regulations, agency guidelines, industry standards, and internal policies to ensure compliance.
Participates in internal and external audit activities.
Hires, trains, and manages employees and their activities to ensure high performance and accountability, collaboration, respect for diversity, and employee job satisfaction.
Develops department budget and monitors spending.
Performs other related duties and responsibilities, as assigned.