What are the responsibilities and job description for the Design Assurance Engineer position at Suna Solutions?
Job Title : Design Assurance Engineer II
Pay Rate : $45- $48.00 / hour
Duration : 3-4 months
Location : Hybrid; Minnetonka, MN
Travel : Travel may be required up to 10% of your time.
POSITION SUMMARY :
This position leads quality engineering activities for development projects from conception to commercialization, including development of the risk management file, completion of DHF deliverables, and significant involvement in design verification / validation. This position is also responsible for quality engineering activities to support design changes for commercial products. Through these activities, the Design Assurance Engineer II will verify the quality, reliability, and compliance of mechanical product designs.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES :
These may include but are not limited to :
- Drives mechanical product design quality, reliability, and compliance to 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 quality system development and improvements
- Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
- Supports print specification definitions, development, and changes
- Supports design test and inspection method development and validation
- 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
- Supports internal & external audits
- Supports complaint investigations
- Supports significant investigations related to product quality for commercial products as needed
- Responsible for maintaining a strong collaborative partnership with cross-functional team members and partner organizations that facilitates organizational success by protecting patient / user safety and meeting business needs.
- Perform other related duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES :
Other skills and abilities :
Preferred / Beneficial :
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.
Salary : $45 - $48
