Manufacturing Engineer - Start Immediately

We are searching for a driven Manufacturing Engineer to join our passionate team at Kelly Services in Saint Louis, MO.
Growing your career as a Full Time Manufacturing Engineer is a terrific opportunity to develop productive skills.
If you are strong in teamwork, problem-solving and have the right drive for the job, then apply for the position of Manufacturing Engineer at Kelly Services today!

Kelly Services is currently looking to hire a Manufacturing Engineer to work for one of our top Medical Device clients on-site in St. Louis, MO for a long-term contract position.

Primary activities will include:

• Actively participate in cross-functional MDR Team R+D, QA, Manufacturing, Manufacturing Engineering initiatives to identify and close gaps in the Disposable Equipment/Process Validations, including but not limited to: Multi-vac Form-Fill-Seal Equipment, HiPS Tray Sealer Equipment, PETG Tray Sealer Equipment, Auto-pouch Sealer Equipment

• Perform detailed evaluations of existing/cumulative IQ/OQ/PQ documentation to identify potential gaps to the MDR requirements and/or demonstrate traceability for MDR compliance

• Draft and obtain cross-functional approval of Engineering Rationale/ justification to close qualification gaps where it is deemed physical testing is not required to demonstrate MDR compliance

• Draft Packs equipment validation protocols IQ, OQ, and PQs where it is deemed physical testing is required to demonstrate MDR compliance

• Execute process validations and generate validation reports in instances where protocol failures occur., work with cross-functional team to identify Root Cause of failure, implement CA and revalidate as required

• Mitigation of other Packs process and documentation issues/updates to address MDR requirements e.g. updates to SOPs, PFMEAs, process qualifications, etc.

• Design, evaluation, and qualification of production tooling.

• Perform component level root-cause analysis and resolution to ensure production continuity.

• Assist in generating CAD documentation, authorizing SOP s and test instructions, and creating/updating PFMEAs in accordance with Quality Systems Regulations.

• Resolve manufacturing issues to minimize production downtime.

• Proactively participate on new product and process design teams, as well as perform change coordination that may impact assembly operations and test processes

Qualifications:

• Bachelor degree in engineering or other technical field required

• Knowledge of the medical device industry is preferred

• Knowledge of Quality Systems standards and regulations and Quality Assurance.

• Knowledge of Lean Manufacturing Concepts

• Knowledge of problem solving through the DMAIC process.

• Ability to perform word processing presentation slides, project schedules. ability to analyze data with spreadsheets or similar software.

• Experience with SolidWorks or other computer modeling software.

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

Company Benefits:
● Company offers great benefits
● Advancement opportunities
● Attractive package