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

Edwards Lifesciences Gruppe

Draper (UT)

On-site

USD 90,000 - 125,000

Full time

3 days ago
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Job summary

Edwards Lifesciences Gruppe seeks a Staff Technologist to provide technical and function-specific knowledge to support Operations and Engineering activities. The role emphasizes asset management, equipment maintenance, and manufacturing support across multiple processes.

Responsibilities include leading feasibility studies, managing projects with MS Project/Gantt charts, and coaching technicians while ensuring rigorous documentation and CAPA investigations.

Qualifications

  • High school diploma or equivalent required.
  • 15 years related experience.
  • Associate's degree or equivalent acceptable.
  • 13 years related experience.
  • Required in CNC and micromachining.
  • 15 years previous experience in manufacturing and/or medical device experience.

Responsibilities

  • Act as SME with in-depth knowledge of asset management, equipment maintenance, and manufacturing support.
  • Design, set-up and execute complex feasibility studies, experiments, and tests to develop findings for validation and improvement of equipment and processes.
  • Manage projects using Microsoft Project, Gantt charts, and other tools to ensure on-time, on-budget completion.
  • Collaborate with Engineering on root cause investigations for CAPA; support validation and qualification of equipment.
  • Lead projects to develop new complex tools/equipment for implementation across areas.
  • Develop and sustain processes and procedures, including training methods for users.
  • Update documentation in systems (ECRs, SOPs, Blue Mountain) using JDE, QMS, PLM.
  • Provide coaching to technicians; ensure regular attendance and adherence to procedures.
  • Adhere to environmental health, safety, and quality guidelines in clean room manufacturing.

Skills

Asset management
Equipment maintenance
Manufacturing support

Education

High school diploma or equivalent
Associate's degree or equivalent

Tools

JDE
QMS
PLM

Job description

Innovation starts from the heart. Edwards Lifesciences is 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 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.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

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