Staff Technologist, Maint/Mfg Sppt Eng (2nd Shift)

Edwards Lifesciences; Draper (UT); On-site; USD 85,000 - 135,000; Full time

Job summary

Edwards Lifesciences is seeking a Staff Technologist to support Operations and Engineering with technical expertise in manufacturing and equipment validation.

The role emphasizes leading complex studies, project management, and collaboration with Engineering on CAPA, documentation, and tooling development.

Ideal candidate has extensive experience in CNC/micromachining and a proven ability to guide technicians and ensure GMP practices.

Qualifications

• HS Diploma or equivalent; 15 years related experience.
• Associate’s degree; 13 years related experience.
• Experience in CNC and micromachining required.

Responsibilities

• SME with asset management, equipment maintenance, and manufacturing support.
• Design, set-up and execute complex feasibility studies and tests.
• Manage projects with MS Project and Gantt charts to ensure on-time completion.
• Collaborate with Engineering on root cause investigations for CAPA.
• Lead development of new tools and equipment for multiple areas.
• Design, develop and sustain processes and procedures; train users.

Skills

Project management

Root cause analysis

Communication

Coaching

Education

HS Diploma

Associate degree

Tools

JDE

QMS

PLM

CAD

Job description

Innovation starts from the heart. Edwards Lifesciencesis the leading global structural heart innovation company, driven by a passion to improve patient lives.With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.Our Staff Technologist position is a unique career opportunity that could be your next step towards an exciting future.

Provides technical and function-specific knowledge to support Operations and Engineering activities.

Key Responsibilities:

• Key SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in asset management, equipment maintenance, and manufacturing support activities
• Design, set-up and execute complex feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review
• Manage all aspects of project management, using such tools as Microsoft Project, Gantt charts, etc., to ensure on-time and on-budget project completion, including interfacing with all parties, allocating resources, negotiating competing priorities, mediating conflicting objectives, and escalating issues as needed for resolution
• Collaborate with Engineering on systemic root cause investigations for CAPA
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval
• Lead projects to develop new complex tools/equipment for implementation in multiple areas
• Design, develop and sustain processes and procedures, including methods to train users
• Utilize manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems (e.g., ECRs, Blue Mountain)
• Provide coaching and guidance to technicians
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other incidental duties (e.g. occasional photo copying or deliveries)

Education and Experience:

H.S. Diploma or equivalent 15 years’ related experience or

Associate’s degree or equivalent 13 years related experience Required in CNC and micromachining.

15 years previous experience in manufacturing and/or medical device experience Preferred

Additional Skills:

• Excellent written and verbal communication, interpersonal, and relationship building skills with focus on creating presentations, influencing and conveying recommendations
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
• Strong computer skills, including usage of MS Office Suite; and CAD if applicable
• Extensive knowledge of validation and improvement of automated equipment
• Ability to troubleshoot manufacturing equipment
• Knowledge of material compatibility in the proposed use environment
• Ability to execute the fundamentals of project management
• Extensive knowledge of routine preventive maintenance of production equipment
• Extensive knowledge electrical, mechanical, electronic, pneumatic, and controls
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work independently in completing complex projects, developing work instructions, and providing guidance to advance the competency of other technicians
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.