Must Haves:

• Test method development
• Device builds in cleanroom
• Process Validation,
• Risk management.

Nice to Have:

• New product development experience
• Receiving inspection
• Operator training

The opportunity:

• Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and clients' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

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.
• Oversee prototype builds, train operators and inspectors, develop in-process inspections, validate in-process inspections, manage defect codes, etc.
• 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.

Skills:

• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Education/Experience:

• Bachelor's degree in engineering required.
• 5-7 years experience required.