Reliability Engineer II

1 week ago

Mounds View, Minnesota, United States Primary Talent Partners Full time

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 5-month contract with a potential for extension.

Pay: $ $45.00/hr;
W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

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

  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

3 Main Responsibilities:

  1. Complaint trending
  2. Risk document updates
  3. Supporting Change orders

Education Required:
Bachelor's degree, Engineering discipline preferred

Years of Experience Required:
3-4 years

Top 3 Skill Sets Required:

  1. Risk Management
  2. Trending
  3. Good Documentation Practices

Additional Must-Have Skills:

  • Good Technical writing skills - The candidate will write complaint summaries, investigation, and analysis summaries on the complaints
  • Good communication skills
  • 1+ years of experience in Complaint handling or customer service/technical support experience

Nice to Have Skills:

  • Change control of Medical Devices
  • 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.
  • Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
  • Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
  • Strong project management skills, with the ability to manage multiple priorities and deadlines.
  • Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
  • Proficiency in Microsoft Office Suite and quality management systems (QMS).

*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 *

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