Kelly Services Medical Device Project Engineer in Rochester, New York

Kelly Engineering is currently looking to hire a Medical Device Maintenance of Business (MOB) Project Engineer to work for one of our top Pharma clients on-site in Rochester, NY. (long term contract position)

Position Summary

The Medical Device Maintenance of Business (MOB) Project Engineer is responsible for supporting MOB business critical projects aligned with other manufacturing site priorities. The MOB projects ensure continuity of supply, provide enhanced product quality, product quality investigations, product global expansion and support manufacturing cost improvements. This position will receive primary technical direction from the Portfolio Lead in Rochester, NY and work closely with R&D and Quality organizations in Rochester, NY in addition to two manufacturing sites.

Specific Job Duties

  • Lead and/or provide technical support to MOB projects working with R&D and Operations technical teams to insure project deliverables are met. Project priorities are based on the following criteria:

  • Priority 1: Non-Conformance NC , CAPA, Compliance, Product Recall, Customer Complaints, Critical Manufacturing Issues

  • Priority 2: Manufacturing Supply Chain Continuity e.g. obsolete components

  • Priority 3: Risk Mitigation e.g. alternative sourcing of critical components

  • Priority 4: Manufacturing Efficiency and Process Improvement, Cost Reduction CIP.

  • Leadership and support of key MOB projects in technical areas including product/process development, plastics engineering, analytical chemistry or microbiology.

  • Ensure project plans and timelines are in place for all planned activities including a detailed project charter/scope, risk assessment, and milestone schedule.

  • Responsible for writing, approving and/or executing protocols for project related studies; either in the laboratory, within manufacturing sites or at vendor sites.

  • Core team member for R&D lead projects as appropriate.

  • Lead cross-functional project teams within the project portfolio as appropriate.

  • Ensure project documentation is completed and approved per procedures. Where necessary generate required report writing and documentation.

  • Responsible for initiating and managing Quality Change Requests QCRs to completion.

  • Ability to interact with external consultants and suppliers.

Qualifications and Requirements

  • Bachelor degree in Chemical Engineering, Chemistry, Material Science or related discipline.

  • PMP certification and Master s Degree a plus, but not required.

  • Minimum of 7 years of related work experience.

  • Knowledge and experience in medical device manufacturing processes.

  • Technical knowledge in keys areas: product/process development, plastics engineering, analytical chemistry or microbiology.

  • Ability to be successful within a matrix-reporting environment.

  • Ability to work under the direction of a principal engineering with a good level of independent work

  • Technical experience within an FDA regulated industry.

  • Demonstrated experience with lean techniques and principles preferred.

  • Demonstrated use of 6-Sigma skills and DOE skills highly desirable.

  • An ability to analyze and manage technical issues across multiple technical disciplines.

  • Strong leadership capabilities.

  • Critical thinking skills.

  • Excellent project management, organizational, and documentation skills

  • Proven track record of delivering to objectives.

  • Strong teamwork and negotiation skills and the ability to influence without authority.

  • Demonstrated ability to work across organizational boundaries.

  • Excellent communication skills and ability to influence at all levels of the organization.

  • Excellent verbal, writing and computing skills. Familiar with MS Office, MS Project, and statistical evaluation software. Managerial Reporting and Responsibilities: There are no direct reports for this position.

  • Ability to interact with external consultants and suppliers.

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 2017 was $5.4 billion. Visit 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.