Senior Manufacturing Engineer - T2 Biosystems
Lexington, MA 02421
About the Job
Description
We are seeking an energetic, process driven, and detail-oriented individual to join our team as a Senior Manufacturing Engineer. This is an exciting role that will support our instrument manufacturing operations and is responsible for promoting product quality, supporting instrument manufacturing and continuous process improvement. The position reports directly to the Director, Instrument & Consumables Manufacturing.
The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks and focused on achieving results. S/he will lead by example with a positive, can-do attitude and will apply their critical thinking skills when getting things done. This individual must be able to communicate with team members at all levels and be comfortable both challenging and influencing others and being challenged by others without getting defensive.
In addition to those skills and attributes, we’re looking for someone that thrives in a rapidly growing environment and is interested in developing and advancing their career along with the organization.
The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks and focused on achieving results. S/he will lead by example with a positive, can-do attitude and will apply their critical thinking skills when getting things done. This individual must be able to communicate with team members at all levels and be comfortable both challenging and influencing others and being challenged by others without getting defensive.
In addition to those skills and attributes, we’re looking for someone that thrives in a rapidly growing environment and is interested in developing and advancing their career along with the organization.
Responsibilities
• Support the instrument manufacturing team, working with technicians on complicated electromechanical assemblies.
• Participate in the process of developing, implementing and monitoring detailed guidelines on what needs to be checked and what the quality standards in the Manufacturing process are.
• Drive regular review of Manufacturing process to identify opportunities for improvement.
• Participate in the inspection of finished products, in process assemblies and raw materials.
• Work with Manufacturing and Engineering to identify the root cause of technical issues and recommend solutions.
• Assist in driving timely completion of Non-Conformances while preventing repeat occurrences.
• Work with Manufacturing to determine appropriate quality metrics for all manufacturing processes and report on them as appropriate.
• Utilize quality principles and problem solving skills (A3, RCCA, 8D, Statistical techniques, etc.) to address product design and manufacturing issues.
• Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics.
• Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify effectiveness.
• Support process and product-related deviation activities including tracking and trending.
• Support complaint investigation, recordkeeping and trend reporting.
• Maintain positive and effective communication and collaboration with all levels of the team and our outside partners and vendors.
• Other tasks as needed to support organizational goals and objectives.
• Strong Electromechanical systems experience needed.
• Participate in the process of developing, implementing and monitoring detailed guidelines on what needs to be checked and what the quality standards in the Manufacturing process are.
• Drive regular review of Manufacturing process to identify opportunities for improvement.
• Participate in the inspection of finished products, in process assemblies and raw materials.
• Work with Manufacturing and Engineering to identify the root cause of technical issues and recommend solutions.
• Assist in driving timely completion of Non-Conformances while preventing repeat occurrences.
• Work with Manufacturing to determine appropriate quality metrics for all manufacturing processes and report on them as appropriate.
• Utilize quality principles and problem solving skills (A3, RCCA, 8D, Statistical techniques, etc.) to address product design and manufacturing issues.
• Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics.
• Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify effectiveness.
• Support process and product-related deviation activities including tracking and trending.
• Support complaint investigation, recordkeeping and trend reporting.
• Maintain positive and effective communication and collaboration with all levels of the team and our outside partners and vendors.
• Other tasks as needed to support organizational goals and objectives.
• Strong Electromechanical systems experience needed.
Skills and Expertise
• Bachelor’s Degree in engineering related discipline required. Preferred degrees in Mechanical Engineering or Electrical Engineering with good understanding of Electromechanical assemblies.
• Minimum of 5 years of relevant Manufacturing experience in an FDA regulated environment required, ideally within medical device, in vitro diagnostics or pharma industry.
• ASQ or Six Sigma Certification or equivalent is desired.
• Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls required.
• Must be familiar with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations.
• Working knowledge of FDA IVD regulations and guidelines and/or experience with FDA and/or notified body audits strongly preferred but not required.
• Must have strong electromechanical assembly design/mfg. experience.
• Experience working with Quality Systems compliant with EN ISO 13485 and 21CFR Part 820.
• Must be able to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associated with these drawings.
• Must be familiar with relevant inspection techniques and equipment.
• Must have strong technical writing, statistical sampling and data analysis skills; proficient with Microsoft Excel.
• Must demonstrate a sense of ownership and accountability. Works with a results-oriented approach, a sense of urgency, uses sound judgment and has strong attention to detail.
• Experience implementing LEAN systems and processes preferred.
• Minimum of 5 years of relevant Manufacturing experience in an FDA regulated environment required, ideally within medical device, in vitro diagnostics or pharma industry.
• ASQ or Six Sigma Certification or equivalent is desired.
• Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls required.
• Must be familiar with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations.
• Working knowledge of FDA IVD regulations and guidelines and/or experience with FDA and/or notified body audits strongly preferred but not required.
• Must have strong electromechanical assembly design/mfg. experience.
• Experience working with Quality Systems compliant with EN ISO 13485 and 21CFR Part 820.
• Must be able to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associated with these drawings.
• Must be familiar with relevant inspection techniques and equipment.
• Must have strong technical writing, statistical sampling and data analysis skills; proficient with Microsoft Excel.
• Must demonstrate a sense of ownership and accountability. Works with a results-oriented approach, a sense of urgency, uses sound judgment and has strong attention to detail.
• Experience implementing LEAN systems and processes preferred.
Source : T2 Biosystems