Sr. Design Assurance Engineer
Role details
Job location
Tech stack
Job description
The Senior Design Assurance Engineer is a quality engineer responsible for directly supporting medical device product development from concept through commercialization. This role involves working with cross-functional development teams to establish and maintain design control deliverables, manage risk activities, and ensure DHF compliance, all aimed at delivering the highest quality product to customers., * Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
- Lead and complete Design Verification and Validation planning, including active cross-functional root-cause analysis investigation and resolution activities.
- Lead Risk Management activities from product concept through commercialization.
- Support design test and inspection method development, and lead method validation activities.
- Ensure DHF content integrity, completeness, and regulatory/standards compliance, while resolving any gaps collaboratively.
- Support and ensure internal and external audit responses and on-time product re-certifications.
- Establish and ensure objective, measurable, discrete, and verifiable customer and product requirements.
- Define objective component specifications, develop supplied component sampling plans, and conduct vendor qualifications.
- Provide support for biocompatibility and sterilization qualifications.
- Develop and lead other team members, providing work direction to assigned technicians for inspection, testing, and project support.
- Perform other functions as required.
Requirements
- Medical device product development experience
- Design control expertise
- Risk management proficiency
- BS in Industrial Engineering, Engineering, or Business
- Comprehensive understanding of FDA regulations
Benefits & conditions
Additional Skills & Qualifications:
- Statistical and data analysis skills
- Strong supervisory, management, and leadership experience
Job Type & Location
This is a Contract position based out of St Paul, MN.
Pay and Benefits
The pay range for this position is $50.00 - $65.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
