Sr Reliability (Manufacturing) Engineer

JobDiva, Inc.; Mounds View (MN); On-site; USD 76,000 - 90,000; Full time

Job summary

Primary Talent Partners is seeking a Sr Reliability (Manufacturing) Engineer for a medical device client in Mounds View, MN. This 11‑month contract offers $55.00-$65.00/hr on a W2 with no PTO or benefits; ACA-compliant supplemental package available.

Responsibilities include reliability studies, DOE concepts, risk analysis, SPC, and process improvements to meet regulatory standards.

Qualifications

• Bachelor's degree in engineering required.
• Experience with Quality Systems, CAPA, Change Control and Validations.
• Knowledge of Medical Device Regulatory Requirements.
• Experience with Quality & Regulatory Audit activities.

Responsibilities

• Develops, coordinates and conducts technical reliability studies and DOE constructs.
• Recommends test methods and SPC procedures for reliability.
• Completes risk analysis studies for new designs and processes.
• Analyzes performance reports and process control statistics.
• Ensures corrective measures meet reliability standards.
• Develops reliability programs to meet objectives.
• May develop models to identify high-risk units or processes.
• Proposes design or formulation changes to improve reliability.

Skills

Quality Systems

CAPA

Change Control

Validations

Regulatory Audits

Reliability Engineering

Education

Bachelor's degree in Engineering

Job description

Sr Reliability (Manufacturing) Engineer

Primary Talent Partners has a new contract opening for a Sr Reliability (Manufacturing) Engineer with our medical device client in Mounds View, MN. This is an 11-month contract with a potential for extension.

Pay: $55.00 - $65.00/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.

Responsibilities

• 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.

Must Have Skills

• Minimum of a completed bachelor's degree is required, ideally in an engineering discipline


• Previous experience on Quality Systems & CAPA, Change Control and Validations


• Knowledgeable on Medical Device Regulatory Requirements


• Previous experience with Quality & Regulatory Audit activities


• a Reliability Engineer

Primary Talent Partners is an Equal Opportunity / Affluent 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]