manufacturing engineer.
plainsboro , new jersey
posted today
job detailssummary
$45.53 - $63.61 per hour
contract
bachelor degree
category computer and mathematical occupations
reference1070429
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 Plainsboro, NJ area. The Manufacturing Engineer will oversee engineering and project management tasks to address compliance gaps, improve manufacturing processes, and ensure regulatory adherence within the medical device industry, leveraging expertise in quality systems and statistical process control.location: Plainsboro, New Jerseyjob type: Contractsalary: $45.53 - 63.61 per hourwork hours: 8am to 4pmeducation: Bachelorsresponsibilities:
Assist in remediating identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective.
Manage engineering and project management tasks to support remediation projects of increased complexity that may risk products and processes.
Complete projects to evaluate, analyze, and improve existing processes, support new manufacturing process development, and troubleshoot manufacturing processes.
Ensure compliance with company procedures and statutory requirements (US FDA and ISO) by generating all necessary documentation, drawings, and specifications.
Coordinate project team efforts, including developing manufacturing process requirements, specifications, validations, Engineering Change Orders (ECOs), and Engineering Drawings.
Support projects to implement statistical process control (SPC) as needed, analyzing and trending existing process parameters and improving manufacturing yields.
Skills:
Knowledge of Quality System Regulation (QSR), Design Control, Process Validation guidelines, Engineering Change Controls, ISO, and regulatory guidelines.
Experience with Statistical Process Control tools (SPC, Minitab, etc.).
General expertise in chemistry, processing, and materials.
strong understanding of engineering principles and practices.
Ability to prepare complex technical reports and project summaries.
Exceptional problem-solving, organizational, and communication skills.
Education and Experience:
Bachelor's degree in Engineering (Mechanical, Pharmaceutical, Chemical, or Biomedical Engineering).
3+ years of experience in manufacturing engineering within the medical device industry.
qualifications:
Experience level: Experienced
Education: Bachelors
skills:
Manufacturing
Compliance
ValidationEqual 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 HRsupport@randstadusa.com.Pay 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.
