Senior Medical Device Manufacturing Engineer

5 days ago


North Haven, United States Modis Full time

Akkodis is seeking a Senior Medical Device Manufacturing Engineer for a 12–24-month contract position with possible perm conversion with a client located in North Haven, CT. You will support in -service operating systems to ensure sustainability- develop design changes- manufacturing process improvements. You will conduct root-cause analyses of in-service problems. This is a fully onsite position.


Pay/Salary Range: $60.00 to $70.00 per hour depending on experience


Senior Medical Device Manufacturing Engineer job responsibilities include:

• 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.


QUALIFICATIONS:

• BS Engineering – Electrical, Mechanical, Manufacturing Biomedical

• Five plus years of experience in Medical Device, Automotive or Aerospace industries

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

• Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP

• Experience with 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

• Six sigma Certification


If you are interested in this Senior Medical Device Manufacturing Engineer job in North Haven, CT then please click APPLY NOW. For other opportunities available at Akkodis go to


Equal Opportunity Employer/Veterans/Disabled



Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client



To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit



The Company will consider qualified applicants with arrest and conviction records.



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