What are the responsibilities and job description for the Manufacturing Engineer position at Mindlance?

2nd Shift

The manufacturing engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommend and implement improvements to production processes, methods and controls; be responsible for the activities related to installation and validation of production lines as well as the lifecycle management of equipment.

This position supports a 2nd shift production ramp for a medical device manufacturing line, as well as

provide ongoing engineering support on improvements that will impact both 1st and 2nd shift for other lines. The engineer will work closely with a technician to implement improvements on the line and in documentation, develop and build fixturing, qualify equipment, and troubleshoot failures.

Main Responsibilities

Daily support to the manufacturing activities in order to meet established goals for safety, quality, cost

and production.

Maintains systems that support the monitoring of key performance indicators such as yield, nonconforming material or lead time. If indicators show an adverse trend, works with the functional team to plan and implement appropriate changes.

Requires work in controlled access environment and adherence to medical device manufacturing standards and regulations.

Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

Uses basic statistic tools.

Performs installation / validation activities for new or existent production lines, meeting regulatory requirements. That includes equipment, process, product and test method validations.

Identifies, selects, and purchases equipment / fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion.

Has direct relation with vendors to define equipment suitability.

Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.

Has knowledge and expertise on product requirements and specifications.

Understands potential risks related to product malfunctions.

Assures that production lines output meet the specifications of the product.

Has clear criteria of conforming / non conforming product and the test methods used for verifying conformance.

Maintains manufacturing systems such as SAP routers and BOM's current.

Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them.

Supports DL's & IDL's training process.

Leads or supports local cross functional team activities.

Participates in the identification and investigation of Non-conforming products. Uses Root cause problem solving techniques to identify and eliminate causes, implements controls and define preventive activities.

Leads or supports continuous improvement projects for any of the main key areas : safety, quality and production.

Must be independent and proactive in identifying opportunities for improvement.

Must be flexible and reactive in an environment of constantly changing priorities.

Education

Education Level

Major / Field of Study

Education Level

Bachelors Degree (± 16 years) Engineering or related ☒ an equivalent combination of education and work experience

Experience Details

2-4 years working experience on similar roles.

Statistical techniques knowledge (DOE, SPC) is required.

Computer software knowledge (Microsoft Word, Excel, Power Point).

Fluency of English (written and speaking) required.

Desired experience in validation plans for medical industry products and processes and

root cause problem solving methodologies

Knowledge of FDA, GMP and ISO guidelines desired.

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority / Gender / Disability / Religion / LGBTQI / Age / Veterans.”

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com

Regards

Niraj kumar

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