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R&D Engineering Project Manager

Kelly Services


Location:
Plymouth, MN
Date:
04/19/2018
2018-04-192018-05-19
Job Code:
US41ALRR_BH1395814
Categories:
  • Engineering
Kelly Services
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Job Details

Job Title R&D Engineering Project Manager

Jobid US41ALRR_BH1395814

Location: Plymouth, MN, 55446, USA

Description Kelly Services is currently hiring a R&D Engineering Project Manager to work for one of our top Medical Device customers in Plymouth, MN

**osition Summary:**

The R&D Engineering Project Manager will develop, validate, and gain regulatory clearance for reprocessed medical devices for the healthcare industry. Strong focus on leading and driving collaborative cross-functional teams. Will lead the project team for the transition of new products from engineering into production through close cooperation with the third party contract manufacturing partner.

**Essential Job Duties and Responsibilities:**

Serve as project manager of a multifunctional team to drive new product development activities from concept to launch.

Develop and confirm methods for reprocessing of assigned devices

Write verification and validation documentation and conduct required testing as needed

Familiar with all aspects of medical device product development, including design, verification and validation, FDA submission, and design transfer into manufacturing.

Perform reverse engineering to identify functional and performance requirements for reprocessed devices

Design and build (or have built outside of company) new components and assembly tooling

Perform testing and inspection functions including forensics and root cause analysis

Assist regulatory compliance efforts and verification and documentation related to engineering standards

Author, revise, train, and provide support for production work instructions.

Identify new processing needs and perform continuous improvement to support sustaining efforts

Perform reverse engineering to identify functional and performance requirements for reprocessed devices

Proficient in the investigation and management of CAPA’s, root cause analysis, complaints, and escalations.

Lead and facilitate process improvement activities

Other responsibilities may be assigned & not all responsibilities listed may be assigned

**Education, Skills, & Experience Needed to Perform Position Function:**

Bachelor degree in Chemical, Mechanical, Electrical Engineering, Biomedical Engineering, or equivalent.

Minimum of 2 years project management experience – leading complex projects and a multi-functional project team

Prior experience in the medical device industry is preferred

Experience with FDA submissions, writing and conducting test plans, protocols and reports

Proficient in Microsoft Office

Proficient in Microsoft project

Strong statistical skills and knowledge of statistical software

Experience with DOE, FMEA, GMP, and QSR

Ability to work within an ISO structured quality system

Knowledge of engineered materials and fabrication methods

Good planning, multi-tasking, and project management skills

Demonstrated track record of completing projects on time and accomplishing goals

Ability to function independently as well as part of a team

Excellent written and oral communication skills

Ability to manage multiple priorities in fast-paced environment

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States.

\#KVETS4JJ

**Why Kelly** **®** **?**


Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm



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