Manufacturing Engineer

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htmlString" : " u003cdiv u003e n u003c! block u003eWe are seeking a collaborative, process driven, and detail-oriented individual to join our team as a u003cstrong u003e Manufacturing Engineer u003c / strong u003e.

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 Senior Manager, Production Support and New Product Engineering. u003cbr u003e u003cbr u003eThe ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team 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. u003cbr u003e u003cbr u003e n u003c / div u003e u003cdiv u003e n u003c! block u003eIn 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.

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Application Deadline

November 08, 2024

Department

Engineering

Employment Type

Full Time

Location

Lexington, MA

Workplace type

Onsite

Reporting To

Tom Cygan

Responsibilities

htmlString" : " u003cul u003e n u003cli u003e n u003c! block u003eSupport the instrument manufacturing team, working with technicians on complicated electromechanical assemblies.

u003c / li u003e n u003cli u003e n u003c! block u003eParticipate in developing, implementing and monitoring manufacturing quality processes.

u003c / li u003e n u003cli u003e n u003c! block u003eDrive regular review of the manufacturing process to identify opportunities for improvement.

u003c / li u003e n u003cli u003e n u003c! block u003eParticipate in the inspection of finished products, in-process assemblies and raw materials.

u003c / li u003e n u003cli u003e n u003c! block u003eWork with Manufacturing and Engineering to identify the root cause of technical issues and recommend solutions.

u003c / li u003e n u003cli u003e n u003c! block u003eAssist in driving timely completion of Non-Conformances while preventing repeat occurrences.

u003c / li u003e n u003cli u003e n u003c! block u003ePartner with operations and quality leaders on the regular review of quality metrics for all instrument manufacturing processes and provide input as appropriate.

u003c / li u003e n u003cli u003e n u003c! block u003eUtilize quality principles and problem solving skills (A3, RCCA, 8D, Statistical techniques, etc.

to address product design and manufacturing issues. u003c / li u003e n u003cli u003e n u003c! block u003eGenerate quality reports that track cycle times, yields / quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics.

u003c / li u003e n u003cli u003e n u003c! block u003eTroubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify effectiveness.

u003c / li u003e n u003cli u003e n u003c! block u003eSupport process and product-related deviation activities including tracking and trending.

u003c / li u003e n u003cli u003e n u003c! block u003eSupport complaint investigations, recordkeeping and trend reporting.

u003c / li u003e n u003cli u003e n u003c! block u003eMaintain positive and effective communication and collaborate with all levels of the team and outside partners and vendors.

u003c / li u003e n u003cli u003e n u003c! block u003eOther tasks as needed to support organizational goals and objectives.

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Skills and Experience

htmlString" : " u003cul u003e n u003cli u003e n u003c! block u003eBachelor’s Degree in engineering related discipline required, Mechanical or Electrical Engineering preferred.

u003c / li u003e n u003cli u003e n u003c! block u003eMust have strong electromechanical assembly design / manufacturing experience.

u003c / li u003e n u003cli u003e n u003c! block u003eMinimum of 5 years of relevant manufacturing experience in an FDA regulated environment required, ideally within medical device, in vitro diagnostics or biotech industry.

u003c / li u003e n u003cli u003e n u003c! block u003eASQ or Six Sigma Certification or equivalent is desired. u003c / li u003e n u003cli u003e n u003c! block u003eStrong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls required.

u003c / li u003e n u003cli u003e n u003c! block u003eMust be familiar with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations.

u003c / li u003e n u003cli u003e n u003c! block u003eWorking knowledge of FDA IVD regulations and guidelines and / or experience with FDA and / or notified body audits strongly preferred but not required.

u003c / li u003e n u003cli u003e n u003c! block u003eExperience working with Quality Systems compliant with EN ISO 13485 and 21CFR Part 820.

u003c / li u003e n u003cli u003e n u003c! block u003eMust be able to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associated with these drawings.

u003c / li u003e n u003cli u003e n u003c! block u003eMust be familiar with relevant inspection techniques and equipment.

u003c / li u003e n u003cli u003e n u003c! block u003eMust have strong technical writing, statistical sampling and data analysis skills;

proficient with Microsoft Excel. u003c / li u003e n u003cli u003e n u003c! block u003eMust demonstrate sense of ownership and accountability.

Works with a results-oriented approach, a sense of urgency, uses sound judgment and has strong attention to detail. u003c / li u003e n u003cli u003e n u003c! block u003eExperience implementing LEAN systems and processes preferred.

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