Lead Validation Engineer, Mechanical

Micro Systems Engineering, Inc (MSEI) is a pioneer in developing innovative technologies and medical devices that save and enhance the quality of life for millions of individuals living with cardiovascular disorders. The company is dedicated to the design and construction of implantable medical devices for cardiac rhythm management. With more than 30 years of experience, our growing success is based on our company’s core values – innovation, excellence and reliability, thus enabling us to inspire confidence and trust in doctors and patients all over the world. We are continually looking for talented engineers to share in our mission.

Please join us as

:

Lead Validation Engineer, Mechanical

The System Verification & Validation group is looking for a proven Senior Engineer to join them in an innovative, design and validation focused role. The Lead Mechanical Validation Engineer plays a key role within the System Verification and Validation department of the Systems Design & Development division. This position requires in-depth knowledge of mechanical design, and mechanical testing methods, and statistical methods for verification and validation. Prior experience in the verification and validation of medical products and comprehension of medical device regulations and standards (EU and FDA) is essential.

Your Responsibilities

Your Profile

Participates in reviews of mechanically-based product requirements and designs

Is responsible to establish design verification and validation (V &V) plans for an array of medical devices

Ensures that strategic and tactical V & V plans conform to quality system and risk management requirements, and sound validation principles

Oversees and V&V work performed by external vendors for outsourced design services

Performs test method validation to ensure use of adequate test methods

Experience:
>7 years of technical experience in quality or mechanical-design engineering activities related to the verification and validation of medical devices, with an increasing and successful record of achievement.

++ Experience with medical products involving leads used for neurological or cardiac stimulation, is very strongly preferred, but where significant responsibility in other high-tech industries of a similar nature is demonstrated, it may be considered in place of medical products industry background.

Specialized Skills and Knowledge:
Ability to establish verification and validation plans for mechanical products and systems

Use of statistical methods for design verification and validation, and for test method validation

Understanding of failure modes and effects analyses (FMEA) and risk management principles (ISO 14971)

Knowledge of Quality System regulations and standards related to design verification and validation (21 CFR 820, ISO 13485)

Significant level of proactive written and verbal communication skills

High levels of interpersonal and team cooperation skills

Use of standard office applications (e.g. MS office), including project management tools

Self-motivated, self-directed, and the ability to learn quickly

Education:
BS/MS/PhD degree in Mechanical Engineering or related discipline (Physics, Manufacturing Engineering). Advanced degree is preferred; equivalent directly applicable work experience may be considered in place of advanced degree.

Are you interested? Please apply online! We are looking forward to welcoming you.

Location: Lake Oswego(0001)

Working hours: Full-time

Job ID: 11221