Manufacturing Engineer II_US Job at Volt Workforce Solution in Mansfield

You deserve a job you love!

 

Volt is immediately hiring a Manufacturing Engineer located in Mansfield, MA

 

As a Manufacturing Engineer you will:

• Create, update, and maintain equipment service work instructions.
• Organize and write validation protocols associated with the manufacturing process
• Lead and support troubleshooting activities to minimize process downtime or reoccurrence
• Identify key process indicators and collect data to drive manufacturing and yield improvements
• Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices.
• Generation and implementation of change controls and engineering notices (ECO).
• Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
• 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, Regulatory, and Quality Assurance personnel.
• Work on project teams with other internal departments, external vendors, and customers as required.
• Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.

This is a full-time role.

 

Ideal candidate will have:

• BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical
• Lean/Six Sigma Green or Black Belt Certification is a plus
• Minimum of 4 years of experience in the medical device and/or pharmaceutical manufacturing environment.
• Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
• 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.
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others

 

Pay rate is $45-$55 per hour

*Pay range 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.

 

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

 

 

Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

 

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email hr_dept@volt.com or call (866) 898-0005. Please indicate the specifics of the assistance needed.

 

Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.  The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.