Sr Engineer

Responsibilities

• Lead identification, development, and optimization of manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) to continuously improve processes.
• Identify opportunities and implement solutions for redesign of equipment, tools, fixtures, etc. to improve manufacturing and reduce risk.
• Monitor critical control points.
• Drive the development and manage the execution of experiments and tests, including writing and executing protocols to improve products and evaluate source materials and suppliers; establish robust manufacturing processes/test methods based on engineering principles.
• Ensure completion of process validations (TMV/IQ/OQ/PQ), analyze results, and develop reports; collaborate with cross-functional teams to facilitate project success and on-time completion.
• Collaborate with engineers for equipment selection and validation.
• Develop training and documentation materials for production and receiving inspection (e.g., work instructions) to enable seamless knowledge transfer.
• Develop and sustain technical content of risk management files.
• Lead investigation of complex manufacturing product quality and compliance issues (e.g., MRB, NCR, SCAR, CAPA, non-conformances, audit observations) and make recommendations with reports.
• Oversee quality support tasks, give instruction to engineers/technicians, train them, and coordinate work.
• Lead, review, and approve compliant change control.

• Bachelor's degree in Engineering/Science (Materials Science, Mechanical Engineering, Chemistry) required.
• 5-7 years of industry experience in manufacturing/quality engineering.

• Master's degree in Engineering/Science.
• ASQ Certified Quality Engineer (CQE) certification.
• Six Sigma Green Belt or better.
• Experience with automation, software testing, and software validation.

• Proficiency in MS Office Suite.
• Ability to read and interpret engineering drawings.
• Proficiency in statistical techniques.
• Excellent documentation and communication skills, including negotiation and relationship management.
• Ability to translate technical information to all organizational levels.
• In-depth knowledge of Quality Engineering principles, theories, and concepts.
• Application of Six Sigma concepts.
• Application of Quality Engineering concepts.
• Strong problem-solving, organizational, analytical, and critical thinking abilities.
• Understanding of processes and equipment used in assigned work.
• Strong leadership and influence skills.
• Adherence to environmental health, safety, and quality guidelines in a clean-room medical device manufacturing setting.
• Strict attention to detail.
• Professional interaction with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Independent work capability.
• Team-work capability with frequent inter-organizational and outside customer contacts.

• W-2 Contract
• Duration: 24 months
• Location:
  
  Draper, UT 84020
• Pay:
  Up to $53.50/hour

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.