Design Assurance Engineer

Actalent•Minneapolis, MN

33d•$82,000 - $123,000•Onsite

About The Position

As a Design Assurance Engineer, you will play a pivotal role in supporting the development and assurance of new products. You will engage in phase reviews and design reviews, collaborating closely with R&D to manage design inputs and outputs, ensuring adherence to design standards and regulatory guidelines. Your expertise will contribute to the verification and validation processes, including usability assessments, while enhancing quality system deliverables.

Requirements

Degree in Engineering, preferably Electrical or Software Engineering.
Minimum of 2 years related experience or training.
ASQ certification.
Ability to work independently, manage tasks, and lead teams.
Strong communication and technical writing skills.
Understanding of design controls, risk management, statistics, and development processes.
Familiarity with FDA, QSR, and ISO requirements.
Problem-solving capabilities.

Responsibilities

Participate in New Product Development Phase Reviews and lead or participate in Design Reviews.
Collaborate with R&D to define and manage design inputs and outputs.
Review Electrical and Software Design Inputs and ensure Verification/Test Readiness.
Work with R&D and external consultants for project deliverables.
Develop and validate new test methods to meet design standards.
Document risks through Hazard Analysis, DFMEA, PFMEA, UFMEA.
Conduct design verification and validation, including usability assessments.
Manage test protocols, execution, issue investigation, and report analysis.
Improve quality system deliverables and processes.
Support in achieving regulatory approvals and addressing inquiries.
Facilitate transfer from development to production.
Assist in internal and external audits.
Manage statistical support for validations and sample sizes.
Interact with contract manufacturers and suppliers.
Ensure compliance with design controls, international standards, and FDA guidelines.
Implement product stability program.
Adhere to ethical standards, legal requirements, and company policies.

Benefits

10% Annual Bonus, 4 weeks PTO, Holiday Pay
Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.

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