Design Assurance Engineer

Primary Talent Partners; Brooklyn Park (MN); Hybrid; Full time

Job summary

A leading company in medical device manufacturing is looking for a Design Assurance Engineer for a 10-month contract. This hybrid role, requiring strong analytical skills and a focus on compliance, involves working closely with design teams to ensure quality standards are met. Candidates should have a relevant degree and experience in quality assurance, and be ready to contribute from day one.

Benefits

Self-funded ACA-compliant healthcare plan available

Qualifications

• Requires a University Degree and a minimum of 2 years of relevant experience.
• Experience in Quality Assurance is preferred.

Responsibilities

• Ensures compliance with quality standards and regulations.
• Develops risk management architecture and supports design verification.
• Uses statistical analysis tools to analyze quality data.

Skills

Detail oriented

Collaborative

Critical Thinking

Education

University Degree

Tools

Minitab

Job description

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Primary Talent Partners has an open 10 month W2 contract with a large medical device client of ours in the Brooklyn Park, MN area.

Pay Range: $45.00 to $55.00 per hour (No PTO, benefits, etc but self funded ACA-compliant healthcare plan available to opt-in to)
Schedule: Hybrid, minimum 3 days/week onsite, starting in September, minimum 4 days/week onsite required.Responsibilities

Responsibilities may include the following and other duties may be assigned:

• Navigates the complexity of government and industry regulations, including 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), and ISO 14971.
• Ensures Design Quality Assurance-driven initiatives meet objectives in delivering the highest quality products, with supporting tools and processes.
• Acts as a collaborative effective leader or team member in supporting quality disciplines, decisions, and practices.
• Develops and/or supports the development of risk management architecture, supports Design for Reliability and Manufacturability (DRM) targets, supports design and phase reviews, supports design transfer.
• Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
• Develops overall operating criteria to ensure implementation of the quality program according to project, process, and contract requirements and objectives, and ensures compliance of projects and related documents with requirements and standards.
• Reviews design, change specifications, and plans against contractual and/or process requirements, including applicable specifications, materials, tools, techniques, and methodologies.
• Provides or directs verification of device requirements, traceability, and testability.
• Recommends and implements design or test methods for achieving required levels of product reliability.
• Plans and leads test method validation of design verification methods. Responsible for design verification planning and execution, verifying product and software performance meets design requirements.
• Utilizes statistical analysis tools to analyze data, such as Analysis of Variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Completes reports.
• Completes risk management files of new design and updates to released products.
• Conducts evaluation of software systems activities, including requirements, design, development, documentation, integration, test, verification, and validation.

Specialist Career Stream

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors

• Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
• Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of the job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience

Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.

Additional Position Details

• Top 3 Skills Sets Required:
  • Detail oriented
  • Collaborative
  • Critical Thinking
• Main Responsibilities/Day-to-Day Activities:
  • TMV Execution/Design Verification Support
  • Project Document Reviews as the Quality Representative
  • Data Analysis - Minitab experience, confidence intervals, hypothesis testing
• Products Supported: Cardiac Surgery capital equipment and single-use catheters
• Target Years of Experience: 3-6 years
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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