The Manufacturing Engineer is a key Operations representative for MR-guided interventional catheters and related devices. The Senior ME will represent operations and be responsible for successful transfer of new product development projects into production. The Senior ME will also be responsible for completing ongoing continuous process improvement initiatives that support SQDCM. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Knowledge of Process Validations including protocol development and execution.
- 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).
- Support manufacturing implementation and facility transfer while providing technical support to receiving facility.
- 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.
- Advise leadership of developments which may affect profit, schedule and costs.
- Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR’s and CAPA.
- Partner with Manufacturing to develop lean principals to implement solutions for product assembly.
- Contribute to continuous improvements in overall product quality and cost.
- 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.
- •Analyzes workforce space requirements, workflow, equipment layout, and workspace for maximum efficiency.
- Prepare and generate Capital Expenditure Requests (CER) for projects and track spend for both capital and expense dollars.
- Bachelor’s degree or higher in Manufacturing or Biomedical Engineering.
- 2-4 years minimum experience in the manufacture of disposable of 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 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 DFMEA and PFMEA.
- Proficient with Solidworks.
- Light work, exerting up to 20 lbs. of force or less.
- Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
- Requires fingering, repetitive motion, talking and hearing.
- Significant work pace & pressure due to deadlines
- Travel 10-15%
To apply, please submit your resume and cover letter documents below.
|Position reports to:||Manager, Manufacturing Engineering|