Manufacturing Engineer I

SUMMARY: The Manufacturing Engineer will be responsible for creating, documenting, developing, and implementing procedures used to assemble, process, test and manufacture medical devices. In addition, you will support teams to deliver on Microline Surgical’ s mission to passionately provide solutions to improve the quality of life for everyone.

This is a hands-on role requiring an individual who is a team player, has excellent communication skills, and the ability to work concurrently on multiple initiatives or projects. Keys for success in this role include your ability to creatively solve problems and make improvements to meet business objectives set by management.

ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

1. Estimate production times, staffing requirements, and related costs to provide information for management decisions.
2. Work with engineering, management, and operations teams regarding manufacturing capabilities, production schedules and other considerations to support production.
3. Apply statistical methods to estimate future manufacturing requirements.
4. Improve existing operations, incorporating new methods, processes, and train operators.
5. Support the evaluation of production equipment performance and make recommendation to either modify or replace to meet demand planning.
6. Lead investigations into operational disruptions affecting output and use RCA tools to effectively and systematically solve problems.
7. Required to present progress at project review meetings to stake holders, process owners and peers.
8. Support teams investigating product DFM.
9. Identify ways to reduce production costs.
10. Review drawing packages and conduct tolerance analysis.
11. Generate and update assembly documentation such as BOM’s and routers using the ERP system.
12. Process engineering change request and work instructions using the QMS.
13. Work with R&D and other departments to produce cost estimates for new designs.
14. Represent Operations as an SME and a Manufacturing Engineering Core Team Member for MPD/NPI initiatives, transitioning new products to manufacturing.
15. Keep up to date with new technology and trends within the industry.
16. Proactively support the evaluation of activities within work cells and apply knowledge of product design, fabrication, assembly, tooling, and materials to resolve problems quickly.
17. Work from written / verbal instructions, specifications, and technical manuals.
18. Lead process IQ/OQ/PQ validations based on project plans.
19. Must be able to work independently, with minimal supervision.

NON-ESSENTIAL FUNCTIONS: In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

Qualifications

1. BS in mechanical or manufacturing engineering with equivalent experience.

1. Strong background in interpretation of Engineering drawings/specifications and manufacturing process planning/evaluation.

1. Knowledge of machine shop practices including milling, turning, and grinding is preferred.

1. Knowledge of Lean and Six Sigma methodologies.

1. Experience with mechanical design using SolidWorks.

1. Knowledge of QMS and ERP systems.

1. Minimum of 2 years of related experience – preferably in the medical device industry.

1. Good written and verbal communication skills.

1. Must have demonstrated ability to work as part of a team.

1. Strong analytical and problem-solving skills.

1. Must be self-motivated and work with a sense of urgency.

REASONABLE ACCOMMODATION: Microline Surgical is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.

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