Senior Manufacturing Engineer
Company: Imricor Co
Posted on: February 25, 2021
The senior-level 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
- 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
- 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
- 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
- Complete on time project updates, project hours, development
plans, self-assessments, and successful completion of all training
- ---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
- 5 years minimum experience in the manufacture of disposable of
medical devices such as catheters, steerable sheaths and
- 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
- 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. Working Conditions
- 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
- Significant work pace & pressure due to deadlines
- Travel 10-15% To apply, please submit your resume and cover
letter documents below. Caution: The Advantage-MR EP
Recorder/Stimulator, Vision-MR Ablation Catheter, and Vision-MR
Dispersive Electrode have received CE mark approval and have not
yet been approved for use in the United States.
Keywords: Imricor Co, Burnsville , Senior Manufacturing Engineer, Engineering , Burnsville, Minnesota
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