Job Description

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:

• 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
• An equivalent combination of experience and education may be considered

Other skills and abilities:

• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred
• Strong statistical data analysis skills
• Ability to manage multiple projects
• Excellent verbal and written communication skills
• Able to work independently as well as in a cross-functional team environment
• Ability to educate stakeholders, customers, suppliers, and management
• Customer focused and service oriented
• Acts on their strong desire to make a difference, partner with others and put ideas into action
• Be engaged by a work culture that is team-oriented, fast paced and progressive

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 partnering with external organizations (customers and suppliers) to complete projects
• Experience with 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.

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