The Senior Manufacturing Engineer will be responsible for identifying and completing ongoing continuous process improvement initiatives that support LEAN manufacturing principles that lead to improvements in Safety, Quality, Delivery, Cost and Moral (SQDCM). The Senior Manufacturing Engineer will also be a key Operations representative for MR-guided interventional catheters and related devices. Much of this function will be grounded in serving the manufacturing team in the cleanroom. In addition, they will collaborate with all key functional areas to assure a smooth and timely transition of new products and are designed for manufacturability. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the Company’s environmental, health, and safety policy.
- Advise leadership of developments which may affect SQDCM.
- Identify continuous improvement opportunities and Apply LEAN Manufacturing Principles, SQDCM, 5S, Line Balancing etc. to assigned areas of responsibility.
- Analyzes workforce space requirements, workflow, equipment layout for maximum efficiency.
- Partner with Manufacturing to develop lean principals to implement solutions for product assembly.
- Contribute to continuous improvements in overall product quality and cost.
- Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities. (IQ, OQ, PQ).
- Knowledge of Test Method Validations and Process Validations including protocol development and execution.
- Support NPI manufacturing implementation and facility transfer while providing technical support to receiving facility.
- Press for DFM and participate in DFM / DFA activities assuring that production processes /equipment are taken into consideration.
- Participate on projects to concurrently develop assembly methods, tooling, equipment, and processes for new and existing products.
- Provide technical support for production tools including assembly equipment and automation.
- Lead and execute projects with minimal supervision and the ability to plan and document projects.
- Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR’s and CAPA’s.
- Support project team members in achieving business objects related attainment of Safety, Quality, Service, Cost and Project Schedule goals.
- Complete on time project updates, project hours, development plans, self-assessments, and successful completion of all training requirements.
- Prepare and generate Capital Expenditure Requests (CER) for projects and track spend for both capital and expense dollars.
- Other duties as assigned.
- Bachelor’s degree or higher in Manufacturing or Industrial Engineering.
- 5 years minimum experience in the manufacture of disposable medical devices such as catheters, steerable sheaths and mechanisms.
- Understanding of cardiac anatomy and physiology.
- Experience working within a design control system.
- Experience with typical hand assembly medical device manufacturing processes such as soldering, assembly, polymer bonding, and thermoplastic reflowing desired.
- Experience with Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities. (IQ, OQ, PQ).
- Knowledge of statistical and analytical methods such as SPC, SQC and DOE.
- Problem solving and strong communication and interpersonal skills are mandatory.
- Knowledge of Lean principles, 5S, Kaizen Events, Value Stream Mapping and 6 Sigma.
- Knowledge of GD&T.
- Knowledge of DFMA.
- Experience working with Solidworks is a plus.
- Working in a Cleanroom environment is a plus.
Imricor is an equal opportunity employer and encourages diverse candidates to apply.
To apply, please submit your resume and cover letter documents below.
|Position reports to:||Manufacturing Engineering Manager|