manufacturing engineer.
salt lake city , utah
posted today
job detailssummary
$44.38 - $52.16 per hour
contract
bachelor degree
category computer and mathematical occupations
reference1057370
job detailsjob summary:A Manufacturing Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery in the West Valley City, UT area. This position will participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.location: West Valley City, Utahjob type: Contractsalary: $44.38 - 52.16 per hourwork hours: 8am to 4pmeducation: Bachelorsresponsibilities:
Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices.
Provide statistical analysis of the date to support the reports.
Troubleshooting equipment/processes that do not perform as intended during validation runs.
Recommend process/quality improvements as part of validation runs.
Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering,
Skills:
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Knowledge in Organizational Excellence and Lean/Six Sigma.
strong Project Management skills.
Ability to lead teams through complex projects and provide departmental technical leadership.
Must have excellent communication skills and a strong track record of working cross-functionally.
Must have demonstrated ability to think strategically.
Teamwork oriented and self-starter.
Education and Experience:
BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
Lean/Six Sigma Green or Black Belt Certification is a plus.
Experience in validations such as: manufacturing equipment, manufacturing processes, Test Method validation, stability or aging, required.
qualifications:
Experience level: Experienced
Education: Bachelors
skills:
Manufacturing
Validation
Medical DeviceEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected] offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.