Lifecycle Management Engineer

Elite Technical is looking for a Lifecycle Management Engineer for one of its Fortune 100 Medical Device clients. The successful candidate will be responsible for:

- Investigating and analyzing bugs and enhancements in Medical Device Software

- Working closely with Process Improvement Engineers to troubleshoot, solve problems, and provide suggestions for future improvements

- Creating design solutions utilizing engineering methods with good documentation processes, generating and releasing design history files in accordance with the company design control process

- Conducting review and execution of software verification testing

- Assisting with concept development under the supervision of Product Development Engineers, or be assigned to special projects as needed

- Using expertise to improve operational efficiencies and meet compliance requirements

- Maintaining a schedule of deadlines and tasks, and possess the ability to prioritize effectively

Required Skills

* BS in Engineering or related field (BSME/BSCS/Biomed,etc)
* Regulatory experience or exposure (FDA/Gov't/Military/HC)
* Experience with documentation in a regulatory environment
* 2-3 years product development or design control experience
* experience with CAD (NX preferred)
* Design Verification/Validation exp
* GMP/QSR/ISO exp
(+) understanding of code/code design
(+) Knowledge of FDA 501(K) submissions
(+) knowledge of orthopedic anatomy and medical terminology
(+) Exp with test scripts
(+) understanding of surgical processes
(+) Agile familiarity

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Location

Warsaw, IN

Openings

1

Anticipated Start Date

Monday, October 18, 2021

Job Type

Contract

Anticipated Duration

1-2 years

Date Posted

Tuesday, September 21, 2021

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Elite Technical Services, Inc. participates in the E-Verify program to confirm the employment eligibility of all persons hired. This means that we will provide the Social Security Administration (SSA) and, if necessary, the Department of Homeland Security (DHS), with information from each new employee's Form I-9 to confirm work authorization. Elite Technical Services, Inc. will not use E-Verify to pre-screen job applicants.

Elite Technical Services, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.