Senior Manufacturing Engineer, Medical Devices

Summary:

The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings, and read and interpret blueprints.

Job Responsibilities:

• Lead identification, development, and optimization of complex Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities & implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to improve manufacturing processes and reduce overall process/product risk profile.

• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/methods based on engineering principles; ensure completion of comprehensive process validations (IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion

• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes

• Develop technical content of risk management files including usability plans, workflow analysis, risk management plans, risk management worksheets, design failure modes and effect analysis

• Develop test methods for receiving inspection and validate test methods (TMVs) which include authoring and executing protocols along with issuing reports

• Develop fixtures and validate fixtures (TFIQs)

•Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/methods based on engineering principles; ensure completion of comprehensive process validations (IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion

• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes

• Develop technical content of risk management files

• Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCAR, CAPA, non-conformances, audit observations) for all supplier production processes and based on engineering principles; analyze results, make recommendations and develop reports

• Train, coach, and guide lower level employees on more complex procedures

• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

Other incidental duties:

• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.

• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.

• Evaluate data and write reports to validate or indicate deviations from existing standards.

Education/Experience:

• Bachelor's degree in engineering required.

• 5-7 years experience required.