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Beverly, Massachusetts, United States of America, United States of America
Onsite
Position Description:
Responsible for process design, development, and material selection to support new and improved extruded catheter sub-assemblies; perform and maintain polymer rheological characterization program to shorten material selection process and benchmark melt properties; coordinate Mechanical as well as Chemical property testing of polymer through the use of design software to include SolidWorks, etc.; order, implement and perform installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) on new equipment, new products and existing product changes for tooling design and development; execute Test Method Validation (TMV) activities for extrusion processes, ensuring accuracy, repeatability, and compliance with industry standards; review new applications to leverage existing technologies; provide Process Engineering support and direction for development runs and potential problems for manufacturing of medical devices; present extrusion concerns at Material Review Board meetings; deploy Lean Six Sigma methodology using methods including Design of Experiments (DOE), Statistical Process Control (SPC), Failure Mode Effects Analysis (FMEA), and FDA Quality System Regulations (QSR) to solve and implement production improvement projects in extrusion; perform data analysis with Minitab; author and institute written technical specifications through document control systems for new and existing process, as required under ISO 9001, ISO 13485 and Current Good Manufacturing Practices (cGMP); collaborate with Quality and leveraging DMAIC process in root cause investigation and implement corrective actions for customer complaints; and collaborate with overseas customers regarding process changes. Relocation assistance is not available for this position. #LI-DNI.
Basic Qualifications:
Requires a Master’s degree in Mechanical, Materials, or Plastics Engineering or related engineering field and two (2) years of experience as a materials or extrusion process engineer or related occupation. Must possess at least two (2) years of experience with each of the following: Extrusion process and project engineering; ISO 9001, ISO 13485, and cGMP; DOE, SPC, FMEA, QSR, IQ/OQ/PQ, and technical writing; Test Method Validation; polymer rheological characterization; Mechanical & Chemical property testing of polymer; and DMAIC process, root cause analysis, and implementation of corrective action.
Salary: $108,800 to $163,200 per year
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below: