Mechanical Reliability Engineer needed for medical device company

RESPONSIBILITY AND AUTHORITY

Provide Product Development Quality Assurance support for the following tasks and duties:

Facilitate from a Compliance, Quality Engineering, and Development perspective the launching of new or improved products/processes. Develops and implements new and updated Quality System procedures for ISO/QSR, such as Verification and validation protocols, long term product stability testing programs, product & material specifications, design & development documentation, etc.

Facilitates the development, implementation, and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485:2003, ISO 14971:2007, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

PRIMARY ACTIVITIES

· Provides Quality Engineering support for product development teams.
· Provides robust and effective Design Inputs through the use of VOC, Safety, Regulatory, Requirements, and all applicable points to consider during requirements definition.
· Ensures the development of comprehensive risk management plans including Design and process FMEAs, Risk management Plans and Risk Management Reports.
· Provides robust linkage between design inputs, risk level, and reliability requirements for design outputs.
· Responsible for utilizing effective Quality Engineering techniques such as risk analysis, test method development, design of experiments (DOE’s), statistical data analysis, Wiebull analysis, and development of sampling plans during product development cycle to support development of robust Design Outputs.
· Develops and executes comprehensive quality strategies for design development, verification and validation.
· Works with Product Development to present effective and meaningful phased Design Reviews.
· Supports the development of accurate and compliant Design History Files (DHF)
· Works with Product Development teams in order to ensure all aspects of Design Transfer activities are being met.
· Develops Long term in-house Product Stability Programs.
· Ensure accurate Device Master Records are implemented.
· Ensures that the development is in compliance with the policies and procedures as well as all applicable regulations.
· Supports corporate Regulatory Affairs by providing information for submissions and Annual Reports.
· As required, participates in FDA inspections, ISO Certification, surveillance audits, and customer audits

ADDITIONAL ACTIVITIES

· Investigates field reports and initiates corrective actions, where appropriate.
· Effectively communicates with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations.


TRAVEL REQUIREMENTS

· This position may require business travel.


MINIMUM REQUIREMENTS AND QUALIFICATIONS

· BS in Engineering (biomedical, mechanical, or electrical)
· 5 or more years of related experience.

DESIRED SKILLS AND QUALIFICATIONS

· Master’s degree preferred.
· Prefer 5 or more years experience in the medical device industry, with emphasis in Design Controls, Regulation 820.30.
· Demonstrates excellent organizational and communication skills and proficiency with the MS Office Suite, and statistical software.
· Must be able to work independently with minimal supervision.
· Must exhibit good working knowledge of statistics including coming up with statistical rationales for verification/validations.
· Able to perform and lead up risk analysis including FMEA’s.
· Able to lead projects of major complexity.
· One or more years of experience with international quality standards.