Reliability Engineer II

Primary Talent Partners has a new contract opening for a Reliability Engineer II with our medical device client in Mounds View, MN. This is a 7-month contract with a potential for extension.

Pay: $40.00 - $50.00/hr ; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Description:
The Reliability Engineer II is responsible for ensuring the safety, reliability, and performance of products throughout the product lifecycle. This role partners cross-functionally with Design, Quality, Manufacturing, Regulatory, Supplier Quality, and Operations teams to identify and mitigate reliability risks, execute reliability assessments, and drive improvements that enhance patient outcomes and product performance. The Reliability Engineer II applies engineering principles, statistical methods, and reliability tools to support new product development, manufacturing processes, and post-market activities.

Key Responsibilities:

• Lead and support reliability activities for new product development and sustaining engineering projects.
• Develop and execute reliability strategies, plans, and test protocols aligned with product requirements and regulatory expectations.

Conduct reliability analyses including:

• Fault Tree Analysis (FTA)
• Failure Modes and Effects Analysis (FMEA)
• Design of Experiments (DOE)
• Statistical data analysis
• Support cross functional projects and programs.
• Collaborate with cross-functional teams to investigate failures, conduct root cause analyses, and implement corrective and preventive actions.
• Support Design Verification, Design Validation, and Design for Reliability (DfR) activities.
• Develop accelerated life testing and environmental stress testing methodologies.
• Evaluate supplier and manufacturing process reliability and identify areas for improvement.
• Prepare technical reports, presentations, and recommendations for management and project teams.
• Support regulatory submissions, audits, and compliance activities as required.
• Contribute to continuous improvement initiatives that enhance product quality, reliability, and operational efficiency.
• Mentor junior engineers and provide technical guidance on reliability methodologies and best practices.

Required Qualifications:

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, Industrial, Packaging, or related field).
• Minimum of 2 years of engineering experience, including experience in reliability, quality, manufacturing, or product development.
• Experience applying statistical analysis techniques and reliability engineering principles.
• Knowledge of risk management and failure analysis methodologies.
• Strong problem-solving and analytical skills.
• Effective communication and collaboration skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications:

• Experience in the medical device, pharmaceutical, aerospace, automotive, or highly regulated industry.
• Knowledge of FDA, ISO 13485, IEC 60601, ISO 14971, or other applicable industry standards.
• Experience with Minitab, JMP, ReliaSoft, MATLAB, or similar statistical/reliability software tools.
• Experience leading cross-functional investigations and risk reduction initiatives.

Key Competencies:

• Reliability Engineering
• Statistical Analysis
• Failure Analysis
• Risk Management
• Root Cause Investigation
• Design for Reliability
• Project Management
• Technical Communication
• Cross-Functional Collaboration
• Continuous Improvement

Must Have:

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Trouble shooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• 2+ years medical device experience
• A Bachelor in Mechanical or Electrical Engineering with ability to build custom fixtures.
• Ability to read drawings, BOMs, GD&T.
• Experience in mechanical assembly and components.
• Ability to work with vendors on dimensions and order components.
• Ability to qualify equipment in medical device mfg. assembly line.
• Experience in working in a med device company in a cleanroom environment.
• Critical manufacturing support.

Nice to Have:

• 1-3 years of Medical Device industry experience
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.

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 View email address on click.appcast.io

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