Sr. Reliability Engineer - Primary Talent Partners

Primary Talent Partners has a 12 month contract opening for a Sr. Reliability Engineer to join a multinational medical device company for an onsite position in Dexter, MI.

Pay: $50.00/hr - $60.00/hr based on experience 
Contract: 12 months, extensions likely, conversion possible
Type: W2, Cannot support C2C or provide visa sponsorship

Summary:
We are seeking a Sr. Reliability Engineer to represent Quality in our Core Team and oversee risk management, test method validation, and the extended team. This will be in support of multiple perfusion products. 

Responsibilities:

• The main responsibilities consist of Risk Management, Design Assurance, and Design Control. 
• 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. 

Required Qualifications:

• Bachelor’s Degree in Engineering, Science or technical field is required.
• 6-10 years of experience with Risk Management, Design Assurance, and Design Control.
• Expertise in CAPA compliance & investigation techniques.
• Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP.
• Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA.
• Must work well in cross-functional teams and be a self-starter.
• Excellent written and verbal communication skills.
• Excellent organizational skills.
• Computer literacy must include proficiency with MS Office and experience with networks and applications.

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 info@primarytalentpartners.com

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