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 Mansfield, MA area. This role involves leading manufacturing process improvements, tooling design, validation, and cross-functional collaboration to ensure efficient and compliant production of surgical products in the medical device industry.
location: Mansfield, Massachusetts
job type: Contract
salary: $45.53 - 63.61 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Work within cross-functional teams (Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, Manufacturing) to maintain and improve surgical product manufacturing.
- Design, specify, develop, and procure manufacturing tooling, fixtures, and equipment.
- Manage implementation and validation of new or modified manufacturing processes and equipment.
- Support internal and external manufacturing transfers.
- Select and validate replacement materials (polymers, metals, adhesives) for product manufacturing.
- Develop and implement Manufacturing Procedures and Work Instructions.
- Create, update, and maintain BOMs, Routers, and DMRs.
- Provide process engineering expertise to resolve manufacturing issues.
- Lead improvement initiatives to reduce rework, scrap, and labor variance.
- Investigate and resolve manufacturing and supplier quality concerns through the Material Review Board process.
- Knowledge of GMPs, ISO 13485 Design Control, and medical device manufacturing process qualifications (IQ, OQ, PQ).
- Experience with metal processing (machining, polishing, welding), plastics processing, and mechanical assembly.
- Knowledge of machine/tool design and equipment startup (preferred).
- Cleanroom experience (preferred).
- Six Sigma knowledge, with certification preferred.
- Experience mentoring Blackbelts/Greenbelts and using Minitab software.
- Ability to troubleshoot and optimize manufacturing processes to improve uptime, yield, efficiency, and quality.
- Experience in Lean Manufacturing and Continuous Improvement (preferred).
- Understanding of financial accounting for product costing, capital purchases, and project valuation.
- Bachelor's degree in Mechanical, Manufacturing, Materials, or Biomedical Engineering (or equivalent).
- At least 6 years of industry experience, with a background in 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
