Senior Reliability Engineer

Redbock - an NES Fircroft company; Mounds View (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Redbock - an NES Fircroft company in Minnesota seeks a Sr. Reliability Engineer for a 12-month contract at Mounds View. You will lead reliability studies, DOE constructs, and risk analyses to drive product quality and regulatory compliance.

You will support multiple sites, manage CAPA and change control, and collaborate across functions to ensure post-market reliability activities meet standards.

Qualifications

• 5-15 years of experience with quality and product activities.
• Knowledgeable on Medical Device Regulatory Requirements.
• Experience with Quality Systems & CAPA, Change Control and Validations.
• Experience supporting post-market reliability activities.

Responsibilities

• Develops reliability studies and DOE constructs.
• Recommends design/test methods and SPC procedures.
• Analyzes performance data and variables affecting products/processes.
• Ensures corrective measures meet reliability standards and conducts risk analyses.
• Proposes changes to improve system/process reliability.
• Determines environmental testing needs and sampling for statistical validity.

Skills

Manufacturing support

Project and program support

CAPA and cross functional collab

Job description

Sr. Reliability Engineer (12-month contract // Mounds View, MN):

Top 3 Required Skills:

• Manufacturing support
• Project and program support
• CAPA and cross functional collaboration

Primary Responsibilities:

• Supporting multiple sites
• CAPA Support
• Understanding quality/post market quality deliverables

Target Years of Experience:

5-15 years of experience with quality and product activities

Duties:

• 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 Haves:

• Previous experience on Quality Systems & CAPA, Change Control and Validations
• Knowledgeable on Medical Device Regulatory Requirements
• Previous experience with Quality & Regulatory Audit activities
• Experience supporting post-market reliability activities