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Kelly Services Manufacturing Engineer in Lakewood, Colorado

JOB TITLE: Manufacturing Engineer

Location: Lakewood CO

Pay rate: $35.00-$40.00/hr. DOE

Duration: 6-12 month Contract with the possibility of temp to hire

Kelly Services is seeking a skilled Manufacturing Engineer that has experience in the medical device or pharma field.

Specific to this role, there are two major activities this individual will help with:

  1. MDR transition

  2. Will be responsible to help perform document review, product testing and documentation activities associated with our products' transition from MDD to MDR (European regulations).

  3. Requires an understanding of GDP and good design control practices in the medical device field.

  4. Requires the ability to maintain good laboratory practices to collect data, and a working knowledge of statistical methods to analyze data

  5. Requires the ability to collaborate as a member of multiple large teams.

  6. Requires the ability to drive tasks to completion on a required schedule.

  7. Understanding of standards and MDR requirements a plus

  8. Specification remediation.

  9. Responsible for driving this project forward. This Activity involves aggregating information about historical parts and generating descriptive documentation and updated specifications.

  10. Requires b-e from above

  11. Requires experience in 3d modelling, preferably in Solidworks

Requires the ability to independently work with team members to locate, aggregate, recreate, and correct historical documentation.

JOB SUMMARY

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include equipment design and development, tests of materials, preparation of specifications, process study, research investigations, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

  • Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.

  • Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ and final documentation in accordance with acceptable engineering practices.

  • Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.

  • Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.

  • Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.

  • Provides work direction to engineering support staff.

  • Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.

  • Follows department processes and regularly makes recommendations on these processes.

  • Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.

  • Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.

  • Analyzes data and presents it in appropriate forums.

  • Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.

OTHER DUTIES AND RESPONSIBILITIES

  • Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).

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

MINIMUM QUALIFICATION REQUIREMENTS

Education

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

  • Bachelor of Science Degree in Engineering, preferred.

Experience

  • Minimum 2 years’ experience.

  • Two years of GMP manufacturing experience required.

Skills

  • Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.

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

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

  • Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.

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

  • Knowledge and ability to implement FDA or regulatory requirements as necessary.

  • 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.

Qualified and Interested candidates should email resume and references for consideration to ray.brown@kellyengineering.com .

Kelly Services, Inc. is an Equal Opportunity Employer.

Why Kelly ® ?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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