Kelly Services Automated Manufacturing Mechanical Engineer in Lakewood, Colorado

Note: This is a full-time, direct-hire,No C2C, 3rd party or H-1B at this time. This position is ONSITE in Lakewood, CO (80215). We appreciate all of our applicants, but we are not able to sponsor at this time. Will pay up to 105k with a 7% bonus

Automated Manufacturing Mechanical Engineer

JOB SUMMARY

Sr level engineering position providing technical support for development and qualification of automated manufacturing systems for a medical device company. Position is expected to provide direction to resources internal and external to the organization while mentoring junior engineers and technicians. Responsibilities include gathering requirements from internal customers, interfacing directly with machine integrators and ensuring system performance meets customer requirements. Quick learner candidate is best suited for success with common activities including documentation of system requirements, oversight of machine build, acceptance testing, installation and debug, qualification at site location and providing post validation production support. Engineering resources will be working within a cross functional matrix, based in Denver Colorado, requiring travel to domestic machine integrators and offshore manufacturing location.

ESSENTIAL DUTIES

  • Design, installation and validation of automated systems for medical device manufacturing in a clean room environment.

  • Assumes accountability for delivery of complete manufacturing systems; starting with design inputs, concluding with design transfer.

  • Maintains knowledge of latest technology and design practices to keep organization current with industry development.

  • Perform independent evaluation, selection, and application in making adaptations and modifications to projects.

  • Assigned total project leadership responsibilities of major capital projects.

  • Provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.

  • Implements and understands FDA or regulatory requirements as necessary.

  • Highlights risks and understands how to complete tasks, avoiding serious delays and considerable expenditure of time and resources.

  • Advises team members pro-actively on technical ideas and promotes skill development of team work.

  • Interacts with peers across projects to secure resources and commitments.

  • Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.

  • Presents effectively complex technical information/analysis, and responds to questions from technical staff members and management.

  • Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).

OTHER DUTIES AND RESPONSIBILITIES

  • Work direction responsibility may include technicians and junior engineers.

  • May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

  • Travel to domestic suppliers and offshore manufacturing site expected 10% - 15%.

MINIMUM QUALIFICATION REQUIREMENTS

Education

  • Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

  • Bachelor of Science Degree in Engineering, preferred.

Experience

  • Minimum 6 years experience specifying, building and qualifying manufacturing systems.

  • Two years of GMP manufacturing experience required.

  • Medical Device and or Pharmaceutical manufacturing preferred.

Skills

  • Requires demonstrated skills in technical innovation, technical leadership, mechanical and or electrical engineering.

  • Knowledge of machine control systems including PLCs, HMI, pneumatic and electrical systems.

  • Preferred experience with Allen-Bradley control systems and Cognex vision systems.

  • Ability to define process requirements from customer input.

  • Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.

  • Strong technical problem solving skills.

  • Mechanical and electronic aptitude to assist with equipment trouble-shooting.

  • Understanding of and adherence to GMP practices and FDA regulations.

  • Demonstrated ability to communicate effectively both verbally and in writing.

  • Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.

If interested directly email resumes to jenh374@kellyservices.com

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 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.