Sr Reliability Engineer - Exempt

Lancesoft

Minneapolis, MN

Apply

JOB DETAILS

SALARY

$60

SKILLS

Analysis Skills, Code of Federal Regulations, Continuous Improvement, Cross-Functional, Design Verification, Detail Oriented, Documentation, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Hazard Analysis, Human Factors, ISO (International Organization for Standardization), Implants, Leadership, Management Strategy, Medical Equipment, Patient Safety, Performance Modeling, Process Development, Product Safety, Product Testing, Project Lifecycle, Regulations, Reliability Engineering, Risk Analysis, Risk Management, Statistics, Team Player, Usability Engineering, Validation Testing, Work From Home

LOCATION

Minneapolis, MN

POSTED

1 day ago

We are currently seeking a highly skilled professional to join our team in a critical role within the Neuromodulation and Pelvic Health division. This position is based in Fridley, Minnesota, offering the unique advantage of working onsite four days a week with the flexibility of remote work on Fridays.
Responsibilities

Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis.
Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability, and Post-Market Quality) to ensure all hazards associated with medical devices are identified, and risks are estimated, evaluated, and that product/system performance is quantifiably predicted.
Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
Evaluate the impact of potential issues on patient safety and product performance.
Perform and document Risk Assessments and communicate results to leadership and cross-functional teams.
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members.
Identify and act upon opportunities for continuous improvement of the Risk Management Process.
Provide input to design/process development, design controls, and design validation to achieve required levels of product safety and performance.
Create documentation in compliance with applicable procedures to meet project deliverables.

Qualifications

Experience with implantable medical devices.
Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.G., Product Hazard Analysis, Design and Process FMEA, User Analysis).
Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).
Experience with Design Control Deliverables including Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.
Experience in the application of statistics.
Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.
Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.
Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.

Join our team and contribute to the advancement of medical device safety and performance in a dynamic and collaborative environment.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Resume Resources

Free Resume Templates Free Resume Builder