Design Assurance Manager

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 $135,000-165,000. 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 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.

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.
  
  

Requirements

Qualifications

• 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
• 3 years’ experience managing people preferred
• Class III or Class II medical device experience strongly preferred
• Comprehensive knowledge of GMP, ISO 13485, 21 CFR 820, ISO 1497
• Strong communication, analytical, and problem-solving skills
• Demonstrated ability to effectively manage multiple projects and priorities
• Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat
• Experience with electrical and other product safety standards preferred
• Experience in reliability testing, software testing, cybersecurity testing preferred
  
  

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• 85% of time requires viewing and working at computer screen.
• Significant work pace and pressure due to deadlines.
  
  

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.