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 supports complex remediation projects, process improvements, and regulatory compliance within the medical device industry, leveraging engineering expertise, documentation management, and cross-functional collaboration to optimize manufacturing operations.
location: Plainsboro, New Jersey
job type: Contract
salary: $45.53 - 63.61 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Assist in remediating gaps in operations and packaging for EU MDR technical files from an engineering perspective.
- Perform process engineering and project management for complex remediation projects to improve processes and troubleshoot manufacturing issues.
- Generate documentation, drawings, and specifications in compliance with company procedures, US FDA, and ISO requirements.
- Coordinate project efforts, including manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO), and engineering drawings.
- Implement and support statistical process control (SPC), analyze process parameters, and improve manufacturing yields while reducing scrap and errors.
- Conduct technical investigations and provide practical manufacturing solutions under regulatory guidelines for medical device manufacturing.
- Lead or assist with Non-Conformance investigations, resolution implementation, and Corrective and Preventive Actions (CAPA).
- Knowledge of Quality System Regulation (QSR), Design Control, Process Validation guidelines, Engineering Change Controls, ISO, and Regulatory guidelines.
- Proficiency in Statistical Process Control tools (e.g., SPC, Minitab).
- Expertise in chemistry, materials, and processing.
- strong knowledge of engineering principles applied to diverse projects.
- Ability to prepare complex technical reports, project summaries, and correspondence.
- Exceptional problem-solving, organizational, and communication skills.
- Bachelor's degree in Engineering (Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Biomedical Engineering).
- - 3+ years of experience in manufacturing engineering within the medical device industry.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal 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.
