Job Title - Sr Manufacturing Engineer - Medical Devices

Job Location - North Haven, Connecticut (Fully Onsite)

Type: W2 contract.

Responsibilities may include the following and other duties may be assigned.

Support in-service operating systems to ensure continued operation and maintenance and optimization throughout.

Determine, select and implement technically feasible and economically viable alternatives for sustainment.

Analyze and evaluate how to improve a system and/or equipment's sustainability under continued operation, maintenance and unexpected change.

Develop design changes to resolve operational issues, introduce new materials and revises product, process and test specifications to enhance product quality, design integrity, reliability and manufacturability.

Collect and evaluate service use and maintenance data; conduct root-cause analyses of in-service problems (e.g., operational hazards, deficiency reports, parts obsolescence, corrosion effects, reliability and maintainability trends, safety hazards, and failure causes and effects) and implement corrective action.

Must Have: Minimum Requirement

Bachelor or Master’s degree in engineering

FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP

Statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis, Six Sigma

Process Verification & Validation, IQ/OQ/PQ and TMV

DFMEA, PFMEA, Process Mapping and Critical to Quality reviews

DFA/DFM, Design and manufacturing documentation to include specifications, procedures, sampling methods, tolerance studies and GD&T

CAPA, Root Cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts

Dynamic, positive attitude and Strong communication, manufacturing process, product industrialization and leadership, presentation skills

Experience in assembly equipment technologies, well versed in molding, stamping and machining methods.

Education: Bachelor’s degree required, Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.