Title : Design Assurance Engineer, Contractor

Duration: Contract Role

Location : Hybrid; Minnetonka, MN

Pay Rate: $48/hr on W2

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Drives mechanical product design quality, reliability, and compliance with standards and regulations
• Leads and supports on-time completion of design control deliverables
• Critically evaluates mechanical product designs, identifies potential design quality issues, and drives issue resolution
• Leads preparation of risk management files and reports for product releases, and has primary responsibility for risk management activities from product conception through commercialization
• Develops release testing plans for new products
• Leads DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Supports design verification/validation and reliability study execution and deliverables; ensures compliance with quality system regulations
• Supports and ensures on-time execution of Quality Plans for OEM manufacturing for development projects and design changes
• Supports manufacturing process development & qualification for new product commercialization and product changes

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science

3+ years relevant experience within the medical device industry or related function

Other skills and abilities:

Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred

Preferred/Beneficial:

Design for Six Sigma and Critical to Quality training and experience

Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs

Experience of participation in audits

ASQ certification

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington as set forth below.