The Manufacturing Engineer will develop and sustain the operation of a global supply chain consisting of multiple external business partners relat
The incumbent will oversee the manufacturing process development and validation of medical electro-mechanical devices. The position will manage resolution of manufacturing/technical issues as they arise in the course of product development and sustaining engineering. This position will also be responsible for developing and overseeing supply chain performance standards for global supply chain metrics.
Essential Job Functions
· Manage the development and validation of medical device manufacturing and distribution supply chain to comply with all associated regulations and standards and commercial objectives.
· Collaborate with the design team, defining/documenting manufacturing processes, and delivering on the execution of external manufacturing development activities including design, qualification, and validation activities.
· Develop and drive execution of manufacturing process design activities to deliver on time clinical targets and the scale up to a full commercial launch with a Quality/compliance mindset.
· Maintain and execute on project plans, schedules, milestones/goals, budgets, agreements/contracts, and issue resolution within a medical device environment.
· Define, initiate, maintain, and report on supply chain metrics and key performance indicators (KPI) to management.
· Provide effective communications on all relevant issues to peers, manufacturing personnel, and management.
· Govern external contract manufacturer relationships in an appropriate manner to establish, maintain, and improve organization effectiveness.
Experience and Qualifications
· 4+ years of direct manufacturing engineering, process development, supplier quality or quality engineering experience in a medical device manufacturing environment within FDA & ISO regulated environment.
· Direct experience in electro-mechanical product manufacturing (PCBA, Injection molding, manufacturing test, etc.), durable medical equipment and high volume single use disposables manufacturing including sterilization methods and processes is required.
· Experience in medical device manufacturing is required and PMA experience is strongly preferred.
· Complete understanding of GMP and ISO standards in regulated environment is required.
· Process validation, process capability (Cpk), Statistical Process Control (SPC), Six-Sigma, etc. experience is preferred.
· Strong analytical skills including development and sustaining of benchmarking, data collection and trend analysis.
· Track record of driving productivity improvements & cost reduction.
· Strong negotiating skills and ability to develop successful relationships with internal and external customers and suppliers.
· Experience and understanding of ERP/MRP systems.
· Ability to adapt and manage effectively in fast-paced, changing start-up environment.
· Ability to travel 30 – 40%.
· Bachelor’s Degree in Manufacturing Engineering, Industrial Engineering, or Equivalent.
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