Position Title: Sr Engineer Work Location: 7+ Months Assignment Duration: Draper, Utah 84020 Work Arrangement: Onsite
Position Summary:
Lead identification, development, and optimization of Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for continuous process improvement initiatives. Identify opportunities & implement solutions for re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes and reduce overall process/product risk profile.
Background & Context:
Role supports department clean room medical device manufacturing and related Quality / Environmental Health and Safety guidelines.
Key Responsibilities:
Lead identification, development, and optimization of Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for continuous process improvement initiatives.
Identify opportunities & implement solutions for re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes and reduce overall process/product risk profile.
Monitor Critical Control Points.
Drive the development and manage the execution of experiments and tests (including writing and executing protocols) to improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/test methods based on engineering principles; ensure completion of process validations (TMV/IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members 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 the seamless knowledge transfer of project and manufacturing processes.
Develop and sustain technical content of risk management files.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., Material Review Board, NCR, SCAR, CAPA, non-conformances, audit observations) for all production processes and based on engineering principles; analyze results, make recommendations and develop reports.
Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and operators and provides feedback; and may coordinate engineers/ technician work.
Lead, review and approve compliant change control.
Qualification & Experience:
Bachelor's Degree in related Engineering/Science field (Materials Science, Mechanical Engineering, Chemistry) with 2+ years industry experience
Master's Degree in related Engineering/Science field (Materials Science, Mechanical Engineering, Chemistry) with 1+ years industry experience
Preferred: ASQ Certified Quality Engineer (CQE)
Preferred: Six Sigma Green Belt or better
Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings
Proven expertise in statistical techniques
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate technical information to all levels of the organizations
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Knowledge of Six Sigma concepts with ability to apply to work product
Knowledge of Quality Engineering concepts with ability to apply to work product
Problem-solving, organizational, analytical and critical thinking skills
Understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change
Knowledge of and adherence to The Organization Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Work is performed independently
Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
Experience with automation, software testing, and software validation is strongly preferred
Bachelor's degree in engineering required.
5-7 years experience required.
Working Conditions & Physical Demands:
Department clean room medical device manufacturing environment; adherence to Environmental Health and Safety and Quality guidelines.
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $53.00/hr - $58.90/hr.
